TRANSLATION FOR GUIDANCE
FRENCH NUCLEAR SAFETY
AUTHORITY GUIDELINES
Conformity assessment of
nuclear pressure
equipment
GUIDE No. 8
Version revised on September 04, 2012
Foreword
The ASN compendium of guidelines brings together documents for
professionals concerned by the nuclear safety and radiation protection regulations
(operators, users or transporters of ionising radiation sources, health professionals).
These guidelines may also be disseminated to various stakeholders,
such as the Local information commissions.
The aim of each guide, in the form of recommendations, is to:
- explain a regulation and the rights and obligations of the
persons concerned by the regulation;
- explain the regulatory objectives and describe, as applicable, the
practices that the French Nuclear Safety Authority deems
satisfactory;
- provide practical elements and useful information on
nuclear safety and radiation protection.
Table of Contents
1. INTRODUCTION
1.1.
1.2.
1.3.
1.4.
1.5.
1.6.
6
CONTEXT AND REGULATORY REFERENCES
SCOPE
PURPOSE OF THESE GUIDELINES
STATUS OF THE DOCUMENT
STRUCTURE OF THE GUIDELINES
ABBREVIATIONS AND DEFINITIONS
1.6.1 Abbreviations
1.6.2 Physical persons and legal entities
1.6.3 Technical definitions
6
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2. GENERAL INTERVENTION PRINCIPLES OF NOTIFIED BODIES AND OPERATOR-SPECIFIC
ORGANISATIONS
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2.1. CLASSIFICATION OF NUCLEAR PRESSURE EQUIPMENT
2.2. CONFORMITY ASSESSMENT PROCEDURES FOR NUCLEAR PRESSURE EQUIPMENT
2.3. SELECTING THE NOTIFIED BODY OR OPERATOR-SPECIFIC ORGANISATION
2.3.1 General rules
2.3.2 Rules of authorisation by ASN of the notified bodies for level N1 nuclear pressure
equipment
2.4. CONFORMITY ASSESSMENT APPLICATION
2.4.1 General description of the equipment, type or assembly
2.4.2
2.4.3
Technical documentation required to start, continue and complete the assessment of
the equipment, type or assembly
Documentation on the quality system implemented by the manufacturer
2.4.4 Information on the production schedule (except module H for level N1 equipment)
2.5. SUBCONTRACTED OPERATIONS
2.6. DRAWING UP WORK REPORTS
2.7. DOCUMENTS ISSUED AT THE END OF THE CONFORMITY ASSESSMENT
3. ASSESSMENT WORK PERFORMED ACCORDING TO THE MODULES EXCLUDING
QUALITY ASSURANCE
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3.1. ASSESSMENT OF THE MANUFACTURER’S RISK ANALYSIS
3.2. ASSESSMENT OF THE EQUIPMENT DESIGN
3.2.1 Full use of a harmonised standard
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Use of a reference system
Examination of the documentation
22
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3.2.4 Experimental method
3.2.5 Prerequisites to the manufacturing operations
3.3. ASSESSMENT OF BASIC AND FILLER MATERIALS
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3.2.2
3.2.3
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Assessment of the capacity of the material supplier’s inspection document to prove
compliance with the essential requirements specified by the equipment manufacturer
3.3.2 Assessment of the EPMN
3.3.3 Manufacturing operations within the context of material development
3.4. EXAMINATION OF THE OPERATING PROCEDURES FOR PERMANENT ASSEMBLIES
3.5. EXAMINATION OF THE QUALIFICATION FOR PERSONNEL BUILDING PERMANENT
ASSEMBLIES
3.6. EXAMINATION OF THE QUALIFICATION FOR PERSONNEL PERFORMING NONDESTRUCTIVE TESTS
3.7. INSPECTIONS DURING MANUFACTURE (MODULES B, F AND G)
3.7.1 Information required for drawing up inspection plans
3.7.2 Minimum inspection frequency (excluding final verification)
3.7.3 Basic materials
3.7.4 Filler materials
3.7.5 Permanent assemblies and welded linings for N1 nuclear pressure equipment
3.7.6 Shaping
3.7.7 Test samples
3.7.8 Heat treatments
3.7.9 Non-destructive tests
3.7.10 Other manufacturing processes
3.7.11 Measuring instruments
3.7.12 Checking parts that will no longer be accessible during the final check
3.7.13 Rules related to component reassignment
3.7.14 Rules related to “supernumerary” productions
3.8. ASSESSMENT OF INSTRUCTION MANUALS
3.9. FINAL CHECK (MODULES F AND G)
3.9.1 Prerequisites to the final check
3.9.2 Documentation review
3.9.3 Visual examination
3.9.4 Pressure resistance test
3.9.5 Marking
3.10. MONITORING OF THE FINAL CHECK (MODULES A1, C1)
3.10.1 Changes to the types of equipment produced
3.10.2 Management of deviations detected by the notified body or the operator-specific
organisation
3.11. TYPE EXAMINATION (MODULE B)
3.12. TYPE-EXAMINATION CERTIFICATE OR DESIGN-EXAMINATION CERTIFICATE
(MODULE B, B1)
3.12.1 Issuing of the certificate
3.12.2 Refusal to issue the certificate
3.12.3 Supplement to a type-examination certificate or design-examination certificate
3.12.4 Renewal of a type-examination certificate
3.13. IDENTIFICATION OF THE NOTIFIED BODY OR THE OPERATOR-SPECIFIC
ORGANISATION
3.3.1
4. WORK TO BE PERFORMED AS PART OF THE CONFORMITY ASSESSMENT
OF ASSEMBLIES
4.1.
4.2.
4.3.
4.4.
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DATA PROVIDED BY THE ASSEMBLY MANUFACTURER OR THE OPERATOR
RISK ANALYSIS
DESIGN ASSESSMENT
CONFORMITY ASSESSMENT OF EACH ITEM OF EQUIPMENT OR INTERMEDIATE
ASSEMBLY
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4.5. CHANGES TO EQUIPMENT OR INTERMEDIATE ASSEMBLIES
4.6. ACTIONS DURING INSTALLATION ACTIVITIES
4.6.1 Actions during building of assemblies
4.6.2 Actions during other installation operations
4.6.3 Data required for drawing up the inspection plans
4.7. ASSESSMENT OF THE PROTECTION AGAINST EXCEEDING THE ALLOWABLE
SERVICE LIMITS
4.8. FINAL CHECK
4.9. MARKING
5. ASSESSMENT WORK PERFORMED ACCORDING TO THE MODULES WITH QUALITY
ASSURANCE (D, D1, E, E1, H, H1)
5.1.
5.2.
5.3.
5.4.
INITIAL ASSESSMENT OF A QUALITY SYSTEM (MODULES D AND D1)
INITIAL ASSESSMENT OF A QUALITY SYSTEM (MODULES E AND E1)
INITIAL ASSESSMENT OF A QUALITY SYSTEM (MODULES H AND H1)
MONITORING THE QUALITY SYSTEM (MODULES D, D1, E, E1, H, H1)
5.4.1 Periodic audits
5.4.2 Unannounced inspections
5.4.3 Management of deviations detected by the notified body
5.5. SPECIFIC ASSESSMENT OF THE QUALITY SYSTEM (MODULES D, D1, E, E1, H, H1)
5.5.1 Modification of the quality system or the production facilities
5.5.2 Change in the scope of the assessment application
5.6. NOTIFICATION OF DECISIONS FOLLOWING QUALITY SYSTEM ASSESSMENT
(MODULES D, D1, E, E1, H, H1)
5.6.1 Initial audit
5.6.2 Monitoring
5.6.3 Information
5.7. DESIGN EXAMINATION CERTIFICATE AND SPECIAL MONITORING OF THE FINAL
CHECK (MODULE H1)
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APPENDIX 1: Rules for classifying nuclear pressure equipment
53
APPENDIX 2: Summary of actions performed by the notified bodies or operator-specific organisations
62
APPENDIX 3: Standard content of an instruction manual
65
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1.
INTRODUCTION
1.1.
Context and regulatory references.
The list of the main legal provisions and texts to which the guidelines refer is as follows:
[1] Article L592-21 of the French environment code.
[2] French Decree No. 99-1046 dated 13 December 1999 on pressure equipment (amended by French
Decree 2007-1557 dated 2 November 2007) transposing the directive 97/23/EC dated 29 May 1997.
[3] French Decree 2007-1557 dated 2 November 2007 on licensed nuclear facilities and monitoring the
transportation of radioactive substances with regard to nuclear safety.
[4] French Order dated 21 December 1999 on the classification and conformity assessment of pressure
equipment.
[5] French Order dated 12 December 2005 on nuclear pressure equipment.
[6] European pressure equipment directive 97/23/EC adopted by the European Parliament and the
European Council on 29 May 1997 on the harmonising of legislation on pressure equipment between
member States.
[7] French Order dated 10 November 1999 on monitoring the operation of the main primary system
and the main secondary systems of pressurised water reactors.
The French Nuclear Safety Authority (ASN) used the following supports to draw up this guide:
 The guide sheets related to application of the directive [6] and the transposing decree [2]
except when the provisions of the order[5] supplementing or clarifying these texts prevail;
 Harmonised European standards;
 The sheets drawn up by the pressure equipment liaison committee (CLAP) which, unless
otherwise stated by ASN, apply to nuclear pressure equipment;
 The sheets from the nuclear pressure equipment liaison committee (COLEN) validated by
ASN and related to new nuclear pressure equipment.
1.2.
Scope
Article 11 of the Order [5] stipulates that the category I to IV and levels N1, N2 or N3 nuclear pressure
equipment undergo conformity assessment carried out by a notified body or an operator-specific
organisation according to one of the assessment modules described in Appendix 2 of the decree [2].
The conformity assessment procedure for assemblies composing at least one of these nuclear pressure
equipment items is described in Article 12 of the order [5].
These guidelines apply to all notified bodies and operator-specific inspection organisations affected by
implementation of these conformity assessment procedures which have been accredited by ASN
according to the conditions of the ASN/GUIDE/5/1 guidelines, i.e.:



The approved organisations mandated by ASN for the performance of all or part of the
conformity assessment procedure of N1 nuclear pressure equipment or assemblies containing
at least one of these equipment items;
The organisations approved for conformity assessment within the conditions of module H for
N1 nuclear pressure equipment;
Notified bodies and operator-specific inspection organisations approved for the conformity
assessment of N2 and N3 nuclear pressure equipment or assemblies containing at least one of
these equipment items.
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1.3.
Purpose of these guidelines
The purpose of the ASN guidelines No.8 is to explain the principles and conditions under which the
notified bodies and operator-specific inspection organisations approved by ASN for the conformity
assessment of nuclear pressure equipment and assemblies containing such equipment perform their
work according to the provisions stipulated in Articles 11 and 12 of the order [5] and the assessment
procedures described in the decree [2] referred to by said order.
It falls within the scope of ASN’s responsibilities with regard to monitoring the design and
manufacturing of pressure equipment specially designed for nuclear application provided for in
Article [1] of the French environment code.
ASN also uses these guidelines to mention the actions incumbent upon the manufacturers and
operators of the nuclear pressure equipment required for application of the provisions regarding
notified bodies and operator-specific inspection organisations.
Other conditions and practices may be substituted for those recommended herein after approval by
ASN, if they meet the corresponding regulatory objectives.
1.4.
Status of the document
Further to publication of the order [5], a working group from the Central Committee for Pressure
Vessels (CCAP) was created, during the meeting of 26 September 2006 of the standing nuclear section
(SPN), in order to draw up guidelines on the conformity assessment of nuclear pressure equipment.
SPN proposed to adopt the draft guidelines that the working group presented during the meeting dated
4 December 2008 and considered that they could be revised after a period of application. These draft
guidelines became the ASN guidelines No.8 published in its version dated 31 March 2009.
Late 2010, at the request of the conformity assessment stakeholders, ASN implemented an approach
with the aim of revising guidelines No.8 dated 31 March 2009 in order to take into account feedback
from its application, all the discussions and observations regarding conformity assessment made since
publication of the order [5] as well as the technical positions expressed by the COLEN on new nuclear
pressure equipment.
1
Accordingly, on 29 December 2010 ASN created a working group bringing together representatives
from the industry involved in the conformity assessment of nuclear pressure equipment in particular
manufacturers and organisations. This working group met 14 times between 19 January 2011 and
6 June 2012 and proposed draft modifications of the ASN guidelines No.8 which were presented to the
advisory committee for nuclear pressure equipment (GP ESPN) during its meeting dated 5 July 2012.
These guidelines abrogate the previous version of the guidelines No.8 dated 31 March 2009 and include
the recommendations made by the GP ESPN.
1.5.
Structure of the guidelines
The ASN guidelines No.8 successively explain:




1
The general intervention principles of the notified bodies and operator-specific inspection
organisations;
The assessment work to be carried out according to the modules except for quality assurance;
The assessment work to be carried out according to the modules in addition to quality
assurance;
The work to be carried out for conformity assessment of the assemblies.
Nuclear pressure equipment liaison committee
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The appendix includes the following:


A table outlining the classification of nuclear pressure equipment (appendix 1);
A table summarising the actions taken by the notified bodies or operator-specific inspection
organisations for each conformity assessment module (appendix 2). It refers to the detailed
description of work to be performed which is explained in the body of the guidelines;
A model instruction manual (appendix 3).

1.6.
Abbreviations and definitions
1.6.1 Abbreviations
APCRP
AP
APP
APSRP
ASN
CLAP
COLEN
CPP
DESP
EIE
EES
EPMN
END
ERP
ETPR
ESPN
PP
PPP
PS
QMOAP
QMOS
QPAP
QT
TS
Autre partie contribuant à la résistance à la pression – Other part contributing to pressure
resistance
Autre partie – Other part
Autre partie sous pression – Other pressure part
Autre partie susceptible d’engendrer un risque vis-à-vis de la résistance à la pression – Other part
likely to create a risk with respect to pressure resistance
Autorité de sûreté nucléaire – French nuclear safety authority
Comité de liaison des appareils à pression – Pressure equipment liaison committee
Comité de liaison des équipements sous pression nucléaires – Nuclear pressure equipment liaison
committee
Circuit primaire principal – Main primary system
Directive équipements sous pression – Pressure equipment directive (PED) 97/23/EC dated
29 May 1997
Partie essentielle pour l’intégrité de l’équipement – Essential part for equipment integrity
Exigence essentielle de sécurité – Essential safety requirement
Evaluation particulière de matériau propre au domaine nucléaire – Specific assessment of nuclear
material
Essais non destructifs – Non-destructive testing (NDT)
Exigence essentielle de radiation protection – Essential radiation protection requirement
Entité tierce partie reconnue – Recognised third party organisation (RTPO)
Equipement sous pression nucléaire – Nuclear pressure equipment
Partie sous pression – Pressure part
Partie principale sous pression – Main pressure part
Pression maximale admissible définie au point h) de l’article 1 du décret [2] – Maximum allowable
pressure defined in point h) of Article 1 of the Decree [2]
Qualification de mode opératoire d’assemblage permanent – Permanent assembly operating
procedure qualification
Qualification de mode opératoire de soudage – Welding operating procedure qualification
Qualification du personnel en charge des assemblages permanents – Qualification of personnel
responsible for permanent assemblies
Qualification technique – Technical qualification
Température minimale/maximale admissible telle que définie au point i) de l’article 1 du décret [2] –
Minimum/maximum allowable temperature as defined in point i) of Article 1 of the
decree [2]
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1.6.2 Physical persons and legal entities
National regulatory authority for ESPNs:
French nuclear safety authority (ASN)
Notified and approved body2:
A notified body is an organisation that has been approved according to Article 9 of the decree [2],
notified to the European Commission under the terms of the PED (Art. 12) and approved by ASN for
conformity assessment of nuclear pressure equipment pursuant to the order [5]. Notified and approved
bodies are referred to as notified bodies throughout the rest of the document.
Operator-specific inspection organisation:
An inspection organisation inherent to an industrial group approved according to Article 14 of the
decree [2], notified to the European Commission under the terms of PED (Art. 14) and approved for
the conformity assessment of nuclear pressure equipment by ASN according to modules A1, C1, F and
G (excluding level N1) pursuant to the order [5]. The operator-specific inspection organisations are
referred to as operator-specific organisations throughout the rest of the document.
Recognised third party organisation (RTPO):
Organisation recognised by a member State under the terms of the Pressure Equipment Directive
(Art. 13) to carry out QMOAP and QPAP approvals or to approve personnel responsible for nondestructive testing (NDT).
Manufacturer:
Physical person or legal entity which assumes the responsibility for the design, manufacture and
inspection of a product to be marketed under his/her/its name as an item of nuclear pressure
equipment or an assembly containing at least one item of nuclear pressure equipment. The
manufacturer can be responsible for the design, manufacture and inspection on its own or he/she/it
can subcontract all or part of the design, manufacture and inspection process. In this case, the
manufacturer retains liability as the manufacturer.
Subcontractor:
Physical person or legal entity that carries out a design, manufacturing or inspection operation on
behalf of and under the responsibility of a manufacturer in accordance with the requirements defined
and set by the manufacturer.
1.6.3 Technical definitions
Nuclear pressure equipment (ESPN):
Equipment that meets the following conditions is considered to be nuclear pressure equipment:




2
Defined by I of Article 2 of the decree [2], except for equipment which is mentioned in points
“a” to “r” of II of Article 2;
Used or intended for use in a licensed nuclear facility as defined in 2° of Article 4 of French
Act dated 13 June 2006;
Directly used to confine radioactive substances under the conditions defined for their
operation;
Resulting in radioactive releases over 370 MBq in the event of a failure, assessed in compliance
with II of Article 2 of the order [5].
This terminology will be included in a later revision of the order [5]
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An item of nuclear pressure equipment is composed of various parts. The permanent assemblies
attached to pressure parts of nuclear pressure equipment and built under the manufacturer’s liability are
considered to be an integral part of this equipment.
Pressure part (PP):
Part used to pick up the loads due to pressure. These parts can possibly be broken down into main
pressure parts (PPP) and the other pressure parts (APP).
The main pressure parts are composed of the following parts:
 The parts making up the equipment casing. In the case of a vessel, it is designed and built to
contain pressurised fluids. These parts are necessarily in contact with pressurised fluids;
 The parts which are essential for equipment integrity (EIE). According to the guide sheets in
particular 7/6 and 7/8, these parts can be defined as parts whose failure may cause sudden
discharge of the energy contained.
The other pressure parts are used to pick up the loads due to pressure. They may include for example
the nuts and bolts whose failure may lead to a sudden discharge of the energy contained.
Other part contributing to pressure resistance (APCRP):
This part is a component of an item of nuclear pressure equipment designed to contribute to pressure
resistance which, if it experiences function loss, may in the medium to long term result in a loss of the
equipment item integrity or of one of its parts through any failure mode. This may involve for example
components whose function is to support and not strengthen the equipment casing, an anticorrosion
lining or even for a steam generator, antivibration bars of the tube bundle or the tube support plates.
Other part likely to create a risk with regards to pressure resistance (APSRP):
Part of a nuclear pressure equipment item which may directly or indirectly play a role in aggressing the
parts contributing to pressure resistance. It may involve for example a part of an equipment item which
can be detached and needing requirements to ensure its attachment and security (for example bolt from
the reactor coolant motor pump or the internal part of a steam generator).
Assembly:
An assembly is composed of several pressure equipment items with at least one nuclear pressure
equipment item, assembled by a single manufacturer to form an integrated and functional unit. An
assembly may contain intermediate assemblies. An assembly cannot contain a portion of an equipment
item and must necessarily stop at the end of an equipment item. For example, the main primary system
(CPP) of a pressurised water reactor cannot be considered an assembly. The assembly can be
completed by the manufacturer on site or in its workshops.
Intermediate assembly:
Assembly included in a larger assembly referred to as a final assembly. The manufacturer of an
intermediate assembly may differ from the manufacturer of the assembly in which it will be integrated.
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Integration:
All the design and manufacturing actions performed under the assembly manufacturer’s responsibility
and with the aim of ensuring appropriate resistance of the assembly.
Assembling:
The manufacturing actions performed under the assembly manufacturer’s responsibility except for
manufacture of intermediate assemblies or equipment assessed within the framework of the assembly.
Assembling may include operations such as handling, attachment of equipment or intermediate
assemblies on the supports, performance of assembling between the intermediate assemblies or
equipment, installation of heat insulators, performance of inspections and tests.
Installation (Actions):
Actions performed on the pressure equipment or assemblies after they are marketed under the
responsibility of the operator in compliance with the requirements stipulated by Article 13 of the
order [5]. If an item of equipment assembled together which does not comply with the definition of
“integrated and functional unit” is supplied to the operator, the operator shall be responsible for
assembling said equipment under installation even if said assembling is not carried out on site.
Specific assessment of nuclear material (EPMN):
Demonstration given by the manufacturer of a nuclear pressure equipment item for each basic or filler
material making up a nuclear pressure equipment item that complies with the requirements identified in
the risk analysis related thereto. This may involve the requirements of the order [5] and those to which
it refers, requirements related to highly improbable situations or additional requirements as defined in
paragraph 3.1.
Type (see CLAP sheet 149):
Sample that is characteristic of a family that undergoes type examination or design examination.
Note: Regulations also use the word “type” to distinguish vessels, piping, pressure fittings and safety
accessories. This very general acceptance of the word “type” is different from the meaning that is
defined in these guidelines.
Family (see CLAP sheet 149):
A group or version of pressure equipment which is covered by the type examination or design
examination certificate.
Approval of a quality system:
For the quality system, the term “approval” will be used to mean:
 Approval as defined in appendix 2 of the decree [2] in point 6 of modules D and E and point
7 of modules D1 and E1,
 Approval as defined in appendix 2 of the decree [2] in point 6 of module H.
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2.
GENERAL INTERVENTION PRINCIPLES OF NOTIFIED BODIES
AND OPERATOR-SPECIFIC ORGANISATIONS
2.1.
Classification of nuclear pressure equipment
Nuclear pressure equipment is classified into 3 levels based on the amount of radioactivity that could
be released in the event of equipment failure (from N1 to N3 by decreasing order of release) and into 5
categories (0, I, II, III and IV) based on the pressure-related risk.
Figures 1 to 8 and table 6.1 in appendix 1 help to determine the risk category of the various types of
nuclear pressure equipment (safety accessories, vessels, pressure fittings, piping) based on their level
and the nature of the fluid contained therein.
2.2.
Conformity assessment procedures for nuclear pressure equipment
The procedure governing conformity assessment of nuclear pressure equipment is determined by the
equipment manufacturer based on its level, risk category and nature. It results from application of the
modules mentioned in appendix 2 of the decree [2], or the combination of these modules. The possible
choices are presented in tables 2.2 a) and 2.2 b) below:
3
Table 2.2 a)
N1
N2
Pressure or safety
containers or
accessories
Category I or II
G+H
G; B+F; B+C1; B1+F; B+D;
B1+D; B+E; H; H1
Pressure or safety
containers or
accessories
Category III or IV
G+H
G; B+F; B+D; H1
Piping
(except small
diameter piping
specified below)
G+H
G; B+F; B1+F; B+C1; B+D;
B+E; B1+D; H; H1
CPP nominal diameter
piping (DN) ≤ 50 +
piping of the other
systems of category
I or II and of DN ≤
100 as well3 as the
pressure accessories
of the same nominal
diameter that are
connected to them
B+F; B+D; G; H1
Does not exist
N3
The applicable
conformity
assessment
procedures are those
provided by the
order [4]
Refer to table 2.2 b)
Does not exist
This provision will be included in a later revision of the order [5]
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Table 2.2 a)
Pressure
accessories
marked CE
Assemblies containing at
least one category I to IV
item of nuclear pressure
equipment
N1
N2
N3
Not usable if the conformity assessment was based on
module A.
In the other cases, an additional assessment must be
performed by the notified bodies or operator-specific
organisations.
Not usable
Conformity assessment of each nuclear pressure equipment of category I to IV
comprising the assembly when said equipment has not undergone a previous assessment.
Assessment of the integration of the final assembly:
- assessment of the design, which includes among others the assessment of the
protection against exceeding the permissible service limits according to the
conformity assessment procedure determined by the highest level and category for
the equipment to be protected;
- assessment of the assembling of nuclear pressure equipment or intermediate
assemblies making up the final assembly in particular conformity assessment of
the assembling of equipment or intermediate assemblies together in accordance
with the requirements and the conformity assessment procedure determined by
the highest level and category for the equipment in question.
Performance of a final check comprising the operations provided for in 3.2.1 and 3.2.2 of
appendix 1 of the decree [2].
The manufacturer of an assembly comprising at least one N1 item of nuclear pressure
equipment subject to the requirements of appendix 1 of the order [5] must have received
an approval of its quality system according to module H appropriately covering
manufacture of the assemblies.
Table 2.2 b) below specifies the possible conformity assessment procedures for level N3 nuclear
pressure equipment based on their risk category:
Table 2.2 b)
Without Quality Assurance
Series
Unit
With Quality Assurance
Series
Unit
Cat. I
A
A
Cat. II
A1
D1 (Production) or E1 (Product)
Cat. III
B+C1
B1+F
B+E or B1+D or H
H or B1+D
Cat. IV
B+F
G
B+D or H1
H1
The conformity assessment according to module A is solely incumbent upon the manufacturer and
does not require the involvement of a notified body. The manufacturer can decide to apply a
conformity assessment procedure corresponding to an assessment module stipulated for the risks
category of its equipment item or for a higher category.
There are no conformity assessment procedures for category 0 nuclear pressure equipment. With
regard to their design and manufacture, they must comply with best practices and with the radiation
protection requirements of the order [5]. An assembly made up only of category 0 equipment does not
need to undergo a conformity assessment procedure. Whenever such an assembly is integrated in
assembly subject to conformity assessment, the notified body or inspection organisation must ensure
that it corresponds to the definition of an integrated and functional unit.
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2.3.
2.3.1
Selecting the notified body or operator-specific organisation
General rules
The conformity assessment of N1 nuclear pressure equipment subject to the requirements of
appendix 1 of the order [5], as well as that of the assemblies containing at least one of these equipment
items is performed by the French nuclear safety authority which can commission another body for all
or part of the required operations.
The conformity assessment of level N2 and N3 nuclear pressure equipment as well as those of
assemblies containing this type of nuclear pressure equipment may be performed by a notified body or
an operator-specific organisation. The latter is only involved in the scope of conformity assessment
procedures corresponding to modules A1, C1, F and G of appendix 2 of the decree [2].
A notified body performs the conformity assessment of level N1 nuclear pressure equipment
exclusively4 subject to the requirements of Appendix 2 of the order [5], as well as that of the assemblies
composing N1 level equipment exclusively of this type.
The notified bodies and operator-specific organisations perform their conformity assessment tasks in
accordance with internal procedures based on these guidelines.
2.3.2
Rules of authorisation by ASN of the notified bodies for level N1 nuclear
pressure equipment
ASN selects the notified body that it mandates based on a proposal made by the manufacturer. Once
the mandate is issued, the notified body cannot be changed save in exceptional circumstances.
Different notified bodies cannot be mandated to assess the design, monitor the manufacturing phases
and perform final check of a nuclear pressure equipment item.
If a different notified body is selected to monitor manufacturing of equipment of the same design, the
technical documents required by the regulations must be transmitted for each equipment item and the
design assessed by each notified body.
ASN will examine on a case by case basis the proposals for mandating a different notified body to
monitor the procurement phase of components subject to technical qualification and manufacture of
the equipment to which they are intended. This last configuration must be exceptional.
2.4.
Conformity assessment application
The manufacturer must apply for assessment either to the French nuclear safety authority, the notified
body or the operator-specific organisation, as per the provisions stipulated in paragraph 2.3 within the
timeframe required for a notified body or operator-specific organisation to schedule and perform the
first step in the conformity assessment in compliance with the chosen module. The notified body or
operator-specific organisation will determine whether it has sufficient elements to start the conformity
assessment.
The assessment application must include the items listed in Table 2.4 below depending on the relevant
module(s).
4
This provision will be included in a later revision of the order [5]
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Table 2.4
Written statement
specifying that this
request has not been
made to another body
or organisation.
Agreement by the
manufacturer to provide
free access to its
facilities and to those of
its subcontractors as
applicable
General description of
the equipment, the type
or the assembly
Technical documentation
for assessment
A1
See
§ 2.4.1
See
§ 2.4.2
See
§ 2.4.3
B
B1
X
X
X
X
X
X
X
X
X
X
C1
D
D1
E
E1
F
G
H
H1
X
X
X
X
X
X
X
X
X
(1)
X
X
X
X
X
X
(1)
X
X
Documentation on the
X
X
X
X
X
X
quality system.
Information on the
See
X
X
X
X
X
X
X
X
equipment production
§
2.4.4
schedule.
Agreement to provide a
X
characteristic copy of
the type.
Type examination or
design examination
X
X
X
X
certificate and technical
documentation for the
approved type.
Note (1): the technical documents are made available to the notified body by the manufacturer within the context of the inspection
visits of the inspection, test and storage locations to check correct implementation of the obligations resulting from the quality system.
With regard to assemblies, the assessment application will moreover include the list of equipment items
composing the assembly with a list of their classification and level and will state whether the equipment
has been subject to conformity assessment or is assessed within the framework of the assembly.
2.4.1
General description of the equipment, type or assembly
The general description must include the following information:
 Manufacturer’s name and address.
 List of any subcontractors.
 Identification or description of the equipment, type or assembly.
 General documentation describing the equipment, type or assembly.
 Installation conditions.
 Definition of the physical limits of the equipment or assembly.
 For each item of equipment and possibly each compartment:
- Fluid contained, state and group;
- Maximum allowable pressure PS;
- Minimum and maximum design pressures (vacuum),
- Minimum and maximum temperature TS;
- Minimum and maximum design temperatures;
- N1, N2 or N3 level;
- Risk category.
 For the assemblies, their function.
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2.4.2
Technical documentation required to start, continue and complete the
assessment of the equipment, type or assembly
Table 2.4.2 below states the type of technical documentation that the manufacturer must transmit or
hold at the disposal of the notified body or operator-specific organisation. This list must be adapted
depending on the relevant conformity assessment modules and must be broken down for each
subcontractor as applicable.
Table 2.4.2
Prior to
assessment
During
assessment
(2)
Before the end
of assessment
(1)
Data supplied by the operator or the manufacturer of the
assembly consistent with the safety report (3):
- Sets of situations in which the equipment or assembly can be
found
X
- Description of the situations and sets of loads to be taken
into account
X
- Data on the radioactive nature of the fluid
X
- Requirements for highly improbable situations
X
- Requirements on in-service inspections
X
- Specific requirements on materials in relation with the
intended application
X
- Other additional requirements
X
Data supplied by the manufacturer (3):
- List of harmonised standards and solutions adopted to meet
the requirements of the order [5] (codes, technical standards,
etc.)
X
- Risk analysis taking into account all the operator – supplied
data on pressure risk and radioactive nature of the fluid
X
- Description of the methods used for in-service inspections,
bearing in mind the radioactivity
X
- Design drawings, production drawings, diagrams of
components (to draw up the inspection plans as applicable),
subassemblies or circuits, key to understanding the drawings
and diagrams (if necessary)
- Solutions adopted for marking and labelling
- List of basic materials used and proof that the material is
suitable for the given application including technical
qualification files when required
X
X
(manufacturing
drawings if not
already
submitted)
X
X (4)
Note (1): if modules B1 and H1 are applied, the documentation must be supplied prior to the end of the design assessment. For all
modules, priority should be given to early examination of the documentation.
Note (2): the documents must be submitted within a timeframe to allow their assessment before performance of the relevant operation.
With regard to modules E and E1, the technical documentation is provided by the manufacturer to the notified body as part of the
inspection visits of the inspection, test and storage locations to check proper implementation of the obligations resulting from the
quality system.
Note (3): the manufacturer is responsible for filing the technical documentation. The notified body or operator-specific organisation
keeps the data transmitted by the manufacturer or operator in accordance with its approval reference system.
Note (4): the relevant items concerning proof of the suitability of the material with the given application may appear in an initial
version of the EPMN transmitted at the start of the assessment.
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Tableau 2.4.2
Prior to
assessment
During
assessment
(2)
- EPMN for the basic materials and filler materials
- Specifications for the supply of the basic materials and filler
materials
X
- Traceability procedures for the basic materials and filler
materials
X
- Notes justifying the calculation thickness in the case of a
design by calculation and any other predimensioning
document for N1
X
- Design notes justifying correct equipment behaviour for
each possibility of damage from the different cases of load
combinations
- Programme for design by experimental method or by
calculation supported by tests
X
X
- Test reports for experimental method design or design by
calculation supported by tests
X
- Procedures or methods used for shaping, assembling
(welding data package) including welding coatings if N1 and
repair, heat treatments and non-destructive testing
X
- Instruction manual
X
- Documents on the qualification and if required the approval
of the operating procedures for permanent assemblies
including for repair (and welded coatings if N1)
X
- Non-conformity reports likely to have an impact on the
requirements identified by the risk analysis and the repair
procedures as applicable
X(5)
- Pressure resistance test procedures as applicable
Before the end
of assessment
(1)
X
X(6)
- Any other document that can be used to show compliance
with the requirements identified by risk analysis
X
X
Data supplied by the manufacturer (7):
- Reports of NDT scheduled by the risk analysis
X
- Data related to heat treatments
X
- Destructive test reports (test samples)
X
- Reports of dimensional inspections scheduled by the risk
analysis
X
- Documents on the inspection of the basic materials and filler
materials
X
- Documents on the qualification and if required the approval
of personnel responsible for producing the permanent
assemblies (and welded coatings if N1) and carrying out nondestructive testing
X
Note (5): the non-conformity report is to be supplied as soon as a deviation likely to jeopardise a requirement identified in the risk
analysis is determined prior to implementation of the selected solution.
Note (6): the procedure must be approved at the design stage if the equipment in particular due to its size or production mode cannot
be subject to the entire pressure resistance test.
Note (7): the data supplied by the manufacturer or the operator is not kept by the notified body.
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The technical documentation mentioned above is to be supplied for the equipment or intermediate
assemblies comprising an assembly which will be assessed as part of the conformity assessment of the
assembly.
With regard to assemblies, the technical documentation must be composed of:
 Relevant elements of the documentation specified in paragraph 2.4.2;
 The assembling list of the assembly (other than between category 0 equipment) specifying for
each assembly, the level and category of each related item of equipment, the intended
assembling mode, the selected assessment module(s);
 For intermediate equipment or assemblies already assessed, the statement and certificate of
conformity and the instruction manual. They must be supplied at the latest before installation
of the assembly equipment;
 The list of safety accessories as well as the level and category of the equipment to be
protected.
The manufacturer of the final assembly must take all the necessary measures so that the notified body
or the operator-specific organisation has all the information concerning the intermediate assemblies or
equipment required for the conformity assessment of the final assembly. Accordingly, it shall ensure
that the above documentation enables the notified body or operator-specific organisation to perform all
the operations mentioned in paragraph 4 of these guidelines.
Where necessary, the notified body or operator-specific inspection organisation must have access to all
or part of the technical documentation used for the conformity assessment of intermediate assemblies
or equipment which have undergone prior individual conformity assessment.
Likewise, the manufacturer of the final assembly must be able to answer any questions posed by the
notified body or the operator-specific inspection organisation regarding the integration of the
intermediate assemblies or equipment exempt from the conformity assessment procedure.
2.4.3
Documentation on the quality system implemented by the manufacturer
In accordance with the provisions stipulated by the modules with quality assurance of appendix 2 of the
decree [2], the notified body must have access to any documentation it deems fit to assess the
manufacturer’s quality system. This documentation must at least include the following information:
 Family(ies) of pressure equipment covered by the quality system.
 Manufacturer’s agreement to meet the quality system obligations and to ensure it is
appropriate and effective.
 Manufacturer’s agreement to inform the notified body of any plan to change a previously
approved quality system.
 Copy of the document certifying the quality system, if it has been certified.
 Manuals or drawings defining the quality objectives, the organisation flow charts, management
staff’s responsibilities and powers with regard to the quality of the pressure equipment.
 Agreement to provide documents on the following subjects during the conformity assessment
of the quality system and the monitoring actions implemented:
- Monitoring of the quality system;
- Design verification;
- Monitoring of the design document modifications (drawings, calculations, specifications
and instructions);
- Procurement of materials, products and components;
- Material and component traceability;
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-
-
Manufacture, inspection and tests;
Programmes defining the inspections and tests to be performed before, during and after
manufacture, with information on their scope and frequency (for example list of
manufacturing and inspection operations, etc.);
Qualification of the operating procedures for the permanent assembly;
Qualification of the personnel responsible for building the permanent assemblies and
carrying out non-destructive testing;
Calibration and verification of the inspection, measurement and testing instruments and
equipment;
Subcontractor monitoring;
Management of non-conformities identified during design, manufacture, inspection,
testing and final verification;
The records for previously manufactured equipment as provided for by the procedures
and the procedure application documents.
2.4.4
Information on the production schedule (except module H for level N1
equipment)
Proper monitoring in the case of the quality modules requires the manufacturer to send the notified
body its planned production schedule for the relevant module and a review every year of the equipment
that has been made bearing the number of the notified body. In the case of modules A1 and C1, each
final check period must also be the subject of such information.
2.5.
Subcontracted operations
Whenever the manufacturer subcontracts operations, the notified body or operator-specific
inspection organisation must have free access to the subcontractor’s premises in order to be able to
perform any inspections there that it deems necessary to check compliance of the requirements
stemming from the risk analysis or as applicable that the manufacturer properly meets the
obligations of the approved quality system.
2.6.
Drawing up work reports
Any work carried out by a notified body or an operator-specific organisation must give rise to the
drafting of a report at least specifying:
 The detail of the service performed;
 The observations made;
 Any deviations identified as well as their management.
The notified body or the operator-specific organisation will decide at its discretion whether it is
possible to transmit the work reports to the manufacturer and under what conditions. The observations
stemming from the inspections must be promptly transmitted to the manufacturer so that it can take all
the relevant corrective and preventive measures as soon as possible.
Work reports must be transmitted to third parties in compliance with the confidentiality requirements
specified in the approval reference system of notified bodies and operator-specific organisations.
2.7.
Documents issued at the end of the conformity assessment
Following a satisfactory assessment, the notified body or the operator-specific organisation issues the
document required by the conformity assessment module applied in accordance with appendix 2 of the
decree [2]. In case of N1 level equipment, the document required under module G is only issued by
ASN after it has checked that the manufacturer is in possession of the valid document required under
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module H.
3.
ASSESSMENT WORK PERFORMED ACCORDING
MODULES EXCLUDING QUALITY ASSURANCE
3.1.
TO
THE
Assessment of the manufacturer’s risk analysis
The notified body or operator-specific organisation will check at least that:
 The risk analysis is not restricted to pressure parts and that it also takes into account the
assembly:
- Essentials safety requirements;
- Radiation protection requirements;
- Requirements relating to highly improbable situations (HIS);
- As required, additional requirements.
 The list of hazardous phenomena and the associated failure modes taken into account
depending on:
- The exhaustiveness of the loads and situations transmitted by the operator,
- The design basis selected such as drawings, materials, etc.
- Feedback from the notified body.
 The appropriate nature of the measures taken by the manufacturer:
- For design and manufacturing conditions eliminating or reducing the hazardous
phenomena;
- To protect against hazardous phenomena which cannot be eliminated;
- To inform the operator through instruction manuals of the residual risks or the incorrect
conditions of use.
This verification is carried out for each situation in which the equipment can be found whether it is
reasonably foreseeable or highly improbable. The requirements which apply to highly improbable
situations are those supplied to the manufacturer by the operator in consistency with the safety report,
in addition to those stemming from the manufacturer’s risk analysis for the situations.
Additional requirements related with the pressure risk may also be defined. They must stem from the
manufacturer’s risk analysis or must be supplied to the manufacturer by the operator in line with the
safety report.
The manufacturer performs a risk analysis which must cover all parts of the equipment and all its life
phases until it is put out of service. The analysis also concerns all actions that the manufacturer
performs under its responsibility before the end of the conformity assessment such as the transport
operations, functional tests or storage conditions.
The risk analysis must also identify the essential safety and radiation protection requirements for which
a visual inspection must be carried out to check compliance therewith and which will form the subject
of the visual examination of the final verification according to the conditions mentioned in
paragraph 3.9.3.
For level N1 nuclear pressure equipment, the manufacturer:
 Performs, during the risk analysis, a classification of the equipment parts depending on their
role with regard to pressure resistance by making a distinction between:
- Pressure parts (PP),
- Other parts contributing to pressure resistance (APCRP),
- Other parts likely to create a risk with respect to pressure resistance (APSRP)
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
Other parts (AP) not representing a risk with respect to pressure resistance.
Describes the requirements which apply to each part.
The analysis of level N1 nuclear pressure equipment is based on a physical and functional
description of the equipment and its parts including the assembling, identification of hazardous
phenomena and the causes of functional losses which help to identify the applicable requirements.
Whenever necessary, the risk analysis must be reassessed or updated. The requirements which apply
to the APSRP are considered additional requirements except for radiation protection requirements.
Flow chart 3.1 summarises the classification approach of level N1 nuclear pressure equipment parts:
Pressure part
Contributing to
pressure resistance
Used to pick up
loads due to the
pressure
Flow chart 3.1
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3.2.
3.2.1
Assessment of the equipment design
Full use of a harmonised standard
The notified body or the operator-specific organisation will check that the requirements stemming
from the risk analysis have been taken into account. This check is carried out on the basis of:
 Appendix ZA of the standard;
 A document from the manufacturer clarifying the additional provisions adopted to meet the
essential safety requirements and the radiation protection requirements which are not
addressed by the standard.
A special analysis must be performed by the notified body or the operator-specific organisation to
assess the validity of the additional provisions adopted including those for highly improbable situations.
The notified body or the operator-specific organisation will check that the provisions of the standard
have been satisfied and that the manufacturer has applied them including the additional provisions.
3.2.2
Use of a reference system
The manufacturer may choose a technical reference system composed of a code, non-harmonised
standards, or even technical specifications. The notified body or the operator-specific organisation will
check in this case that the requirements stemming from the risk analysis have been taken into account.
This check is carried out on the basis of:
 An integral part of the code clarifying the provisions set therein to meet the requirements
stemming from the risk analysis and a document outlining the additional provisions adopted
to meet the essential requirements which are not addressed by the code;
OR
 An analysis supplied by the manufacturer explaining how the provisions of the reference
system meet the requirements stemming from the risk analysis.
In all cases, a special analysis must be performed by the notified body or the operator-specific
organisation to assess the validity of all the provisions adopted. The notified body or the operatorspecific organisation will check that all stages of the reference system have been satisfied and that the
manufacturer has applied them including the provisions for highly improbable situations and the
additional requirements stemming from the risk analysis.
Except in the case of an analysis provided by the manufacturer explaining how the provisions of the
reference system meet the requirements stemming from the risk analysis, the rule in the case where a
code is used is to use a single code for an item of equipment in a given version identified in the
technical documentation. Subsequent modifications of the given version of the code may be chosen by
the notified body subject to the following conditions:




They can be explicitly declared as being compatible with the given version by the publisher of
the code;
The manufacturer justifies that the modifications maintain the consistency of the chosen
provisions and therefore compliance with the applicable requirements;
The agreement of the notified body or operator-specific organisation is explicitly given;
The manufacturer takes account of any conditions associated with their application.
In general, the manufacturer must provide proof that the modifications of the reference system used
allow the requirements stemming from the risk analysis to be met.
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3.2.3
Examination of the documentation
This examination concerns the technical documentation defined in paragraph 2.4.2, in particular the
appended drawings and documents (e.g. equipment specifications, etc.). In general, the check concerns
the following:
 Overall examination of the equipment dimensions and geometry (body, blend radii, supports,
fastenings, nozzles, etc.);
 The conformity of the types of assembly with the chosen technical reference system;
 Due consideration of the applicable requirements (identification of the areas subject to fatigue,
equipment selected for in-service inspection by taking into account radioactivity, marking,
draining and ventilation methods, radiation protection requirements, etc.);
 Consistency of the data within the drawings and documents and with the risk analysis status,
The examination of the notified body or the operator-specific organisation concerns the following in
the case of a design by calculation:
 Conformity of the input data to the situations and loads supplied by the operator;
 The geometric data taken into account;
 Conformity of the material characteristics included with the characteristics guaranteed by the
harmonised standard or the material assessment (refer to paragraph 3.3);
 Checking that the method:
- complies with the applicable technical reference system;
- can deal with all applicable requirements taking into account the chosen failure mode;
- is used within its area of validity;
- is implemented with appropriate technical resources;
 Consistency of the output data (a check calculation may be carried out).
3.2.4
Experimental method
The experimental design method is not accepted for modules B1 and H1. For the other modules, it is
only implemented if necessary in addition to a design method or alone for the non-N1 level equipment
whose PSxV product is less than 6000 bar.L or PSxDN product is less than 3000 bar. The conditions
for implementing the experimental design method are specified in point 2.2.4 of appendix 1 of the
decree [2].
3.2.5
Prerequisites to the manufacturing operations
An examination concerning all the irreversible design choices in particular with regard to dimensioning
and the choice of materials must be carried out prior to manufacturing equipment in the scope of the
conformity assessment.
It will include an examination of documentation which will cover examination of the following:
 Justification of the design or the dimensioning thickness,
 Justification of suitability of the material specifications and the equipment selected to enable
in-service inspection,
 Identification of the areas subject to fatigue and the measures taken to prevent this risk as
required,
 Description of the equipment considered for in-service inspections, taking into account
radioactivity.
A good practice is for the notified body or operator-specific inspection organisation to put its
conclusion into writing.
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The examination of the design note justifying the correct behaviour of the as built equipment for each
case of damage, resulting from the different load combinations is not a prerequisite to the
manufacturing operations and must be carried out before the end of the final verification.
3.3.
Assessment of basic and filler materials
The equipment manufacturer must prove that the materials used in its manufacturing process comply
with all the requirements identified in the risk analysis applicable thereto. This may involve the
requirements of the order [5] and those that said order refers to, requirements relating to highly
improbable situations or additional requirements.
These requirements concern the following in particular:
 Equipment design,
 Use of the material, in particular:
- Its chemical and ageing resistance,
- Its capacity for the intended transformation methods,
- Its compatibility with the other materials used,
 The risk of exposure to ionising rays.
The notified body or operator-specific organisation will assess the proof provided by the equipment
manufacturer of compliance with these requirements. For the materials composing pressure parts (PP)
and other parts contributing to pressure resistance (APCRP), the proof is officialised by a special
assessment of the materials inherent to the nuclear field called “EPMN” carried out by the equipment
manufacturer.
The notified body or operator-specific organisation will assess the proof of the material’s suitability
with the intended use which may be demonstrated in an initial version of the EPMN and before the
start of the corresponding manufacturing operations makes sure that:
 The equipment manufacturer has specified the appropriate requirements to the material
suppliers including the radiation protection requirements and essential manufacturing
requirements when applicable;
 The inspection documents drawn up by the manufacturer of the materials certifying
compliance with the requirements specified by the equipment manufacturer meet the guideline
No.7/5 (CLAP sheet 12);
 The certificate with specific inspection on N1 level equipment products of category I to IV is
drawn up for each material comprising the parts contributing to pressure resistance (PP and
APCRP).
The notified body or the operator-specific organisation will assess the capacity of the material
manufacturer’s inspection document to prove compliance with the essential requirements specified by
the equipment manufacturer in accordance with paragraph 3.3.1 below.
When the material manufacturer does not have a quality assurance system that complies with the last
section of point 4.3 of appendix I of the decree [2], the notified body or the operator-specific
organisation will check that the measures taken by the equipment manufacturer in particular with
regard to monitoring or inspecting the product, to ensure the conformity of the material are
appropriate. It assesses if these measures comply with the relevant provisions of standard NF-EN-7645 or provide equivalent guarantees.
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In the case of a basic material taken from a warehouse operator 5 , and for which the material
manufacturer does not guarantee compliance with the requirements of appendix 4 and with the
requirements of points 4 of appendices 1 and 2 of the order [5], this guarantee must be provided by the
equipment manufacturer especially based on a sufficient number of tests performed on the product and
at the appropriate locations6. These tests must be monitored by a notified body or operator-specific
organisation unless they are performed by a laboratory approved according to standard ISO 17025.
3.3.1
Assessment of the capacity of the material supplier’s inspection document to
prove compliance with the essential requirements specified by the equipment
manufacturer.
When the material manufacturer has a quality assurance system certified by a qualified certifying body
within the European community, the notified body or operator-specific organisation responsible for
performing the conformity assessment will examine the justification provided by the equipment
manufacturer to check that this quality system underwent specific assessment covering the
manufacturing processes and properties of the materials in accordance with guideline 7/16 (CLAP
sheet 114).
For requirements for which there is no guarantee that they are covered by the quality system
assessment, the equipment manufacturer must prove to the notified body or the operator-specific
inspection organisation that it has taken the appropriate measures in particular with regard to
monitoring or inspection of the product to ensure that the material used complies with the
requirements.
3.3.2
Assessment of the EPMN
The special assessment of material inherent to the nuclear field is carried out by the equipment
manufacturer in accordance with guideline 9/13 (CLAP sheet 134) for each material comprising
pressure parts (PP) and other parts contributing to pressure resistance (APCRP). They must include or
refer to qualitative and quantitative data justifying that the relevant essential requirements of the order
[5] are met.
Accordingly, the EPMN can be based on tested codes, harmonised standards and existing material files
under order dated 26 February 1974. In this case, the suitability of the reference system used with the
use of the materials must be justified and the notified body or operator-specific organisation will check
that these elements actually help to prove compliance with the applicable requirements.
The equipment manufacturer draws up an EPMN including when it relies on conformity with a
harmonised European standard or European approval of the material. In fact, the EPMN must also
make it possible to prove:
 Compliance with the radiation protection requirements;
 Compliance with the requirements of appendix 1 of the decree [2] not addressed by the
standard or the European material approval (in particular those of point 3.1) and additional
requirements of appendix 1 of the order [5] for N1 level nuclear pressure equipment,
appendix 2 of the order [5] for N2 level nuclear pressure equipment and appendix 3 of the
order [5] for N3 level nuclear pressure equipment, in particular point 4 of appendices 1 and 2
of the order [5];
 Compliance with any requirements related to highly improbable situations or additional
requirements identified in the other situations by the risk analysis.
5
6
Intermediate according to § 6 of standard NF EN 10204 version 2005
Refer to COLEN 7A and 3A sheets
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When the tested codes, harmonised standards and material files mentioned above do not address all or
part of the requirements, the manufacturer may refer to standard NF EN 764-4 for the definition of
the relevant elements to be supplied in order to provide this proof in particular with regard to the test
programmes and studies.
Whenever the material produced is very similar to a material addressed by a harmonised standard or a
European material approval and the material manufacturer already has experience with this material,
the extent of the proof to be provided in the EPMN may be reduced to the requirements constituting
an extension of the scope of the harmonised standard or the existing European material approval. In
this case, the manufacturer identifies in the EPMN those requirements that it considers to be addressed
by compliance with the standard or the European material approval.
The EPMN may also refer to other documents which entail a part of this justification for example the
QMOSs or the qualifications of the shaping operating procedure which forms the subject of an
examination within the context of the equipment conformity assessment. This is especially true for
justification by QMOS of the sufficiency of filler materials after implementation with the given
application.
Each material of each item of equipment has a specific EPMN. In the case of similar materials used for
different applications, common documents may be referenced.
The notified body or the operator-specific organisation will assess the EPMNs based on the conditions
stipulated by the modules or combinations of conformity assessment modules within the context of the
material assessment, audit and visits to assess the quality system as well as performance or monitoring
of the final verification. They take account of the assessments that have already been performed.
3.3.3
Manufacturing operations within the context of material development
The production of equipment is started under the responsibility of its manufacturer in accordance with
guideline 7/19 (CLAP sheet 187) once an operation has been carried out on a material that can affect
its mechanical properties. This operation, for example shaping, machining, assembling, heat treatment,
must meet the essential safety requirements applicable to the manufacturing process used.
Operations similar to manufacturing operations can be performed as part of developing materials. They
do not need to be monitored by the organisation responsible for equipment conformity assessment if:
 The corresponding essential manufacturing requirements are mentioned in the specification
supplied by the equipment manufacturer to the material supplier
AND
 If the material supplier’s quality system has been assessed by a certifying body in accordance
with the requirements of paragraph 3.3.1 above.
In this case, the material supplier’s inspection certificate must also address the essential manufacturing
requirements and as required make reference to the approvals of the operating procedures or the
personnel approvals performed by a competent third party.
In the case of requirements for which the equipment manufacturer does not guarantee that they are
covered by the quality system assessment, it must prove to the notified body or the operator-specific
organisation that it has taken the appropriate measures to ensure that the material used complies with
the requirements in particular monitoring or inspection of the product.
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3.4.
Examination of the operating procedures for permanent assemblies
The notified body or the operator-specific organisation will check that the operating procedures for the
permanent assemblies are qualified and correspond to the type of assemblies to be made and with the
applicable essential requirements of point 3.1.2 of appendix 1 of the decree [2].
The qualification of a permanent assembly operating procedure (QMOAP) must be recorded in a
report on the manufacturer’s letter head (or that of the subcontractor) or that of the examining notified
body where appropriate.
In the case of procedure qualification declared by an entity which may be the manufacturer, the notified
body or a recognised third party organisation, it is possible to take into account for the approval:
 The examinations and tests recognised to be completed in compliance with the appropriate
European standards,
OR
 Any examinations and tests recognised to be equivalent (refer to guideline No. 6/11),
provided that the entity has the necessary technical skills and acts within the framework of a
quality management system that guarantees its independence and objectivity.
The notified body or the operator-specific organisation will check that the QMOAP of the pressure
parts of the equipment of risk category II, III and IV which contribute to pressure resistance and the
parts which are directly related thereto have been previously approved by a notified body. In this case,
the notified body or the operator-specific organisation will check that the approval issued clearly
identifies the operating procedure in question and the notified body or RTPO that issued the approval.
Note: for module B1, guideline No. 4/5 (CLAP sheet 111) stipulates the minimum requirements for the check and approval of
QMOAP during the design phase.
3.5.
Examination of the qualification for personnel building permanent
assemblies
The notified body or the operator-specific organisation will check the provisions adopted by the
manufacturer for qualification of personnel building permanent assemblies to the appropriate degree of
aptitude. The notified body or the operator-specific organisation will check that the qualifications of the
personnel responsible for permanent assemblies are formalised, and valid in terms of time and
appropriateness for the type of assemblies to be built.
The notified body or the operator-specific organisation will check that the QPAP of the pressure parts
of equipment of risk category II, III and IV which contribute to pressure resistance and the parts which
are directly related thereto have been previously approved by a notified body. In this case, the notified
body or the operator-specific organisation will check that the approval issued clearly identifies the
personnel in question, the period of validity of the qualification and the notified body or RTPO which
issued the approval.
Note: for module B1, guideline No. 4/5 stipulates the minimum requirements in terms of the check of approval of personnel building
permanent assemblies during the design phase.
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3.6.
Examination of the qualification for personnel performing non-destructive
tests
The notified body or the operator-specific organisation will check the provisions adopted by the
manufacturer for the qualification of the personnel performing non-destructive tests to the appropriate
degree of aptitude. The notified body or the operator-specific organisation will check that the
qualifications of the personnel responsible for performing non-destructive tests are formalised, and are
valid in terms of the time and appropriateness with the tests to be performed.
The notified body or the operator-specific organisation will check that the qualifications of the
personnel performing non-destructive tests for pressure equipment of risk category III and IV have
been previously approved by a notified body for N2 or N3 level equipment or an RTPO for N1 level
equipment.
In this case, the notified body or the operator-specific organisation will check that the approval issued
clearly identifies the personnel concerned, the period of validity of the qualification, the notified body
or RTPO that issued the approval as well as whether the means or the process that led to the approval
complies with a code of good practices such as CEN/TR 15589 in particular.
Note: for module B1, guideline No. 4/5 (CLAP sheet 111) stipulates the minimum requirements in terms of the check of approval
of personnel performing non-destructive tests during the design phase.
3.7.
3.7.1
Inspections during manufacture (modules B, F and G)
Information required for drawing up inspection plans
The notified body or the operator-specific organisation will perform its monitoring according to an
inspection plan drawn up based on a method defined beforehand and formalised through a procedure.
This method which may depend on the module and the type of equipment must help to define the
inspection plan of each item of equipment from the risk analysis and the identification of the technical
provisions defined by the manufacturer to meet the requirements.
Prior to the start of manufacturing, the notified body or the operator-specific organisation will ensure
that it possesses the required information for drawing up its inspection plan.
This information may be included in the:
 Risk analysis of the equipment or any other document specifying the conditions for complying
with the requirements that it identifies;
 The compendiums, welding data packages, manufacturing sequences, drawings, isometric
drawings, or any other document describing the manufacturing operations;
 The quality plans, monitoring documents or any other document specifying the chronology of
operations.
This examination of the documentation prior to start of the manufacturing must at least make it
possible to check that the documentation supplied by the manufacturer:
 Explicitly describes manufacturing of the overall equipment;
 Is sufficiently comprehensive (in particular with regard to the details of the permanent
assembly processes and the non-destructive testing processes);
 Allows identification of the manufacturing operations during which the provisions which meet
the requirements stemming from the risk analysis are implemented and which help to supply
the manufacturer with the notification points for it to be summoned.
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If the manufacturer does not supply the entire documentation required for drawing up the inspection
plans, the notified body or the operator-specific organisation will assess the consequences and express
an opinion on the manufacturing operations that can be performed.
For N1 level nuclear pressure equipment, ASN decides on when to raise the stop point relating to the
first manufacturing operation of an equipment item based on an explicit opinion given by the mandated
organisation relating to the points above.
3.7.2
Minimum inspection frequency (excluding final verification)
The frequency of inspections performed by the notified body or the operator-specific organisation
within the context of modules F and G, excluding final verification, must be at least that identified in
the table 3.7.2 below:
Table 3.7.2
Inspection goals
Minimum frequency
Basic materials for parts
contributing to pressure
resistance
Check of the connection between the
material certificates and identification
of the material
Shaping
Check that the method is implemented
Heat treatments
Check implementation of heat
treatments
Check of the connection between the
material certificates and identification
of the filler materials for parts which
contribute to pressure resistance
Check of identification of the storage
and use conditions of the filler
materials for parts which contribute to
pressure resistance
At least one check per item of
equipment and extension depending
on the number of materials used
At least one check of each shaping
method per item of equipment
At least one check per item of
equipment
Permanent assembly
(welding)
Other permanent assemblies
At least during a welding operation
and extension depending on the
number of materials used
During a welding operation
Check of the implementation of the
welding operations (from inspection of
the edges to be welded, preheating and
squeezing through to post-heating and
finish grinding, etc.)
At least one check per item of
equipment and extension based on the
following criteria : types of processes,
welded lengths, difficulties of
implementing the processes,
manufacturing times
Check in the workshop that the
personnel performing the operation
has the appropriate level of
qualification or approval
During a welding operation
Check of implementation of other
permanent assembly operations
At least one check of each permanent
assembly method per item of
equipment
Check in the workshop that the
personnel performing the operation
has the appropriate level of
qualification or approval
During a permanent assembly
operation
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Table 3.7.2
Inspection goals
Minimum frequency
Non-destructive tests: X-ray
Examination of radiographs and
associated reports
At least 5 % of the number of
radiographs of an item of equipment,
10% for N1 level equipment and for
all equipment extension according to
the following criteria: thickness, type
of seal, difficulty
Non-destructive tests: Other
methods
Check of implementation of nondestructive tests (preparation, material
check, result traceability)
Check in the workshop that the
personnel performing the test has the
adequate level of qualification or
approval
Dimensional check
Check performance by the
manufacturer of the dimensional check
At least one check per item of
equipment and extension depending
on the difficulties experienced in
performing the measurement
Other operation or
provision identified by the
manufacturer to meet a
requirement stemming from
the risk analysis
Check of compliance with the
procedures
At the discretion of the notified body
or operator-specific organisation
3.7.3
At least one check of each method per
item of equipment
During the check of implementation
of the relevant NDT
Basic materials
For the parts contributing to pressure resistance, the notified body or the operator-specific organisation
will check:
 The existence of the material acceptance documents with regard to the list of planned
materials (conformity with guideline No. 7/5 and 7/8 );
 That the information and results indicated on the acceptance documents conform to the
design data (EPMN);
 The correspondence between the acceptance documents and the identification of the material
(application of the marking procedure).
Where the technical qualification is required for making components for N1 level equipment, the
notified body will examine whether the documentation making it possible to guarantee that these
components have been manufactured in the conditions and according to the procedures in the
technical qualification is available.
For all parts not subject to pressure and welded directly onto the pressure parts, the check is limited to
the grade of the part.
3.7.4
Filler materials
For welding parts contributing to pressure resistance, the notified body or operator-specific
organisation will check:
 The existence of acceptance documents with regard of materials planned (conformity with
guideline No. 7/10 amended by the requirements of the order [5]);
 That the information and results indicated on the acceptance documents conform to the
design data (QNMOS if required, otherwise EPMN);
 The identification of the filler materials during welding operations and their conditions of
storage and use.
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3.7.5
Permanent assemblies and welded linings for N1 nuclear pressure equipment
The notified body or the operator-specific organisation will check that:
 The descriptions of the procedures are available;
 The welding data packages conform to the approved QMOS as required;
 The qualifications and approvals (operating procedure and personnel) have been given before
the building of the permanent assemblies or corresponding linings is started;
 The implementation of the permanent assemblies and linings complies with the operating
procedures for all the parameters mentioned therein. This check includes in particular the
preparation of the assembly (dimensional check, tack welding if appropriate, etc.) and a check
of the pre and post heating phases and building of the assembly.
The notified body or the operator-specific organisation checks in the workshop that the personnel
performing the operation is actually qualified or approved to the appropriate level.
3.7.6
Shaping
The shaping operations mentioned in paragraph 3.7.2 are the operations concerning the parts of the
equipment contributing to pressure resistance, built in the aim of obtaining the required shapes within
the tolerance limits defined by plastic deformation. They can be built on the bending rolls, on the press
or by any other tested process. The notified body or the operator-specific organisation will check that:
 The procedures are available and appropriate for the product to be shaped;
 The implementation conforms to the procedure;
 The results of the inspections defined in the procedure conform to the applicable
requirements.
3.7.7
Test samples
The notified body or the operator-specific organisation will check that:
 The number of test samples corresponds to the applicable requirements;
 All the post-weld heat treatments carried out on the test sample independently of the
component conform to the heat treatment specified for the component;
 In the reports, the conditions of implementation and the results of the destructive and nondestructive test conform to the applicable requirements.
3.7.8
Heat treatments
The notified body or the operator-specific organisation will check that:
 The procedures are available;
 The heat treatment procedure at the work station conforms to the procedures in particular with
regard to loading and position of the thermocouples;
 The recordings of the temperature/time curves or other reports (heat treatment reports, loading
diagrams with positioning of thermocouples) conform to the requirements of the procedures.
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3.7.9
Non-destructive tests
The notified body or the operator-specific organisation will check:
 Availability of the procedures;
 That the personnel qualifications and approvals have been given before the corresponding
non-destructive tests begin;
 Radiographs;
 The conditions in which the radiographs are stored;
 The implementation of non-destructive tests other than by X-ray;
 The test reports.
These examinations are conducted by personnel who have been trained in NDT methods without it
being necessary that a recognised third party organisation approves the personnel.
3.7.10 Other manufacturing processes
The notified body or the operator-specific organisation will check that the implementation conditions
and the results obtained are compliant with the requirements stemming from the risk analysis.
3.7.11 Measuring instruments
The notified body or the operator-specific organisation will perform checks by sampling to ensure the
metrological conformity of the measuring instruments used. This check may be based on standard NF
EN ISO 10012 and will notably concern:

The reference of the metrological management procedure;

The calibration and check frequency;

The validity of the latest check;

The identification of the measuring instruments;

The use of standards and reference materials.
The notified body or the operator-specific organisation will moreover check the consistency between
the metrological characteristics of the measuring instrument including its uncertainties of measurement
and the metrological requirements associated with the use of the results for example the maximum
tolerated error.
3.7.12 Checking parts that will no longer be accessible during the final check
The notified body or the operator-specific organisation will perform a visual inspection under the
conditions defined in paragraph 3.9.3 of all parts that will no longer be accessible during the final check.
3.7.13 Rules related to component reassignment
When the conformity assessment procedures applied involve an individual check, components cannot
be reassigned between equipment items without assessing their consequences on the level of inspection
of each equipment item.
However, components can be reassigned between equipment items after simply informing the notified
body or the operator-specific organisation if they are carried out for equipment of the same type
intended for the same nuclear reactor and manufactured under the same conditions (same workshop,
same process, same period). These conditions make it possible to have an equivalent level of guarantee
over the inspection performed.
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In the other cases, the manufacturer must provide the notified body or the operator-specific
organisation with a file justifying that the reassignment does not jeopardise the conformity with certain
requirements. For example, reassigning components between steam generators of the same design but
which are intended for different facilities must be justified. The notified body or the operator-specific
organisation will then examine the manufacturer’s justification and moreover check that reassignment
does not result in a lesser level of guarantee over the inspection performed. As applicable, it modifies
its inspection plan to notably avoid having a disproportionate imbalance of the number of inspections
per item of equipment.
These rules do not apply to equipment parts for which the risk analysis does not identify any applicable
requirement.
3.7.14 Rules related to “supernumerary” productions
Exceptionally and as a precaution, the manufacturer may request the supernumerary manufacture of
pressure equipment components when their manufacturing process presents a high likelihood of
discards. Each application must be justified and must be studied on a case-by-case basis by the notified
body or the operator-specific organisation which as required will inspect manufacture of these
supernumerary components.
As regards series components subject to the technical qualification requirement, manufacture will be
inspected according to an inspection plan including:
 Influential parameters with the rate of sampling scheduled for the series components subject
to the technical qualification requirement,
 The set of destructive and non-destructive tests which provide a demonstration in the
framework of the technical qualification.
The aim of this provision is to guarantee an inspection level at least equivalent to the equipment for
which they are intended. If these components are used on another item of equipment than that initially
planned, their reassignment is subject to authorisation of the notified body or the operator-specific
organisation (“other cases” of the 3.7.13 paragraph).
3.8.
Assessment of instruction manuals
The instruction manual that accompanies each item of equipment or assembly must, based on the
manufacturer’s risk analysis, be drawn up in order to meet the following goals:
 Provide the user with all the information required for proper use of the equipment with regard
to the 4 points mentioned in a) of point 3.4 of appendix 1 of the decree [2], within the design
limits of the equipment or the assembly. In accordance with point 1.2 of appendix 1 of the
decree [2], the instruction manual must inform the user of the residual risks which were not
able to be eliminated by the adapted design measures and state whether the user must take
special appropriate measures to mitigate these risks. As long as there is a pressure-related risk or
a risk of exposure to ionising rays, the inspections required for preventing said risk must be
mentioned. However, the defect grading criteria do not fall within the scope of the instruction
manual.
 Inform the user, in accordance with points 1.3 and 3.4 c) of appendix 1 of the decree [2], on the
risks related with a proven foreseeable or improper use of the equipment which could not be
eliminated by the adapted design measures and which must be given particular attention
through the implementation of special measures by the operator. These risks may exist for each
life phase of the equipment mentioned in a) of point 3.4 of appendix 1 of the decree [2].
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By virtue of Article 17 VI of the decree [2], the operator of the nuclear facility for which the equipment
or assembly is intended must take account of the instruction manuals when defining its conditions of
use. It is therefore in its interest to precisely outline its expectations to the manufacturer of the
equipment or assembly especially with regards to the information required for implementing its
radiation protection approach.
Instruction manuals must explicitly identify the different types of information which help to meet the
aforementioned goals. The standard content of an instruction manual is presented in appendix 3 to
these guidelines. The sections are to be developed by the manufacturer when they are relevant. The list
is not exhaustive and must be completed by the manufacturer if necessary.
As stated in c) of point 3.4 of appendix 1 of the decree [2], the instruction manual can be accompanied
by the necessary explanatory technical documentation and drawings. It may therefore refer to separate
documents. The information specified then becomes prescriptive and the reference documents must be
enclosed with the instruction manual. It is the manufacturer’s responsibility to determine the
documents to be enclosed with the instruction manual in conjunction with the operator.
The notified body or the operator-specific organisation will check that the instruction manual
comprises the relevant information for each required section mentioned in point 3.4 of appendix 1 of
the decree [2], and will also check suitability with the risk analysis results.
3.9.
Final check (modules F and G)
The final check is a line of defence independent of the monitoring of manufacturing operations. Its aim
is to reasonably ensure that the equipment complies with the requirements identified by the risk analysis
applicable to the relevant zones after application of the manufacturing processes and as required the
storage processes.
3.9.1
Prerequisites to the final check
The manufacturer will be responsible firstly for ensuring that the equipment is in suitable condition
through, among others, visual inspections carried out at the most opportune times. The manufacturer
must keep the relevant elements of its inspection (inspection plan and procedure, reports and detected
deviations, etc.) at the disposal of the notified body or the operator-specific organisation.
The notified body or the operator-specific organisation will carry out the final check based on an
internal procedure. This procedure is submitted to ASN in the case of N1 level equipment or
assemblies subject to the requirements of appendix 1 of the order [5].
Prior to each stage of the final check, the notified body or the operator-specific organisation will make
sure that the necessary safety conditions have been met for performing the check.
The notified body or the operator-specific organisation will also ensure that the operations scheduled
until the end of the conformity assessment will not jeopardise the requirements stemming from the risk
analysis being assessed. As required, it must request that the inspections be performed at a later stage.
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3.9.1.1
Prerequisites to the pressure resistance test
The notified body or the operator-specific organisation makes sure that the equipment is able to
withstand the pressure resistance test in particular by carrying out a prior visual examination.
The notified body or the operator-specific organisation can authorize that the pressure resistance test
be performed without all the deviations being remedied as long as the manufacturer has proven that
these deviations do not jeopardise the equipment’s capacity to withstand the pressure resistance test.
The notified body or the operator-specific organisation must check:
 Identification of the equipment subject to testing,
 The presence of the required marking,
 Regulatory conformity of the pressure resistance test,
 Consistency between the documents used for the pressure resistance test and those mentioned
in the technical documentation.
If the equipment, in particular due to its size or manufacturing method, cannot undergo the entire
pressure resistance test, the test procedure to be followed must be approved at the design stage.
3.9.1.2
Handling deviations before the end of the final check
For all the parts composing an item of nuclear pressure equipment, the notified body or the operatorspecific organisation cannot complete the final check without the manufacturer having properly dealt
with the deviations likely to impact the requirements stemming from the risk analysis including those
detected by one of its subcontractors. If the manufacturer cannot sort these deviations, the notified
body or the operator-specific organisation examines all of them. If there is a sorting procedure, the
notified body or operator-specific organisation will carry out a sample check to make sure that it is
properly implemented.
With regard to the additional requirements such as the case of the APSRP of N1 level nuclear pressure
equipment, the notified body or the operator-specific organisation will implement a sample check of all
deviations handled.
When the conformity assessment procedure does not include quality assurance, the notified body or the
operator-specific organisation informs ASN of any deviation likely to affect previous productions.
3.9.2
Documentation review
The aim of the documentation review of the final check is to ensure compliance of the requirements
identified by the risk analysis:


Exhaustively for the applicable essential safety requirements and ERP as well as for the
requirements resulting from highly improbable situations;
Through sampling for additional requirements.
The technical document that the manufacturer must transmit or hold at the disposal of the notified
body or the operator-specific organisation mentioned in paragraph 2.4.2, must help to prove
compliance with all the requirements identified in the risk analysis.
The manufacturer must draw up reports for the inspections stipulated by the risk analysis, for the
volume and surface NDTs as well as the dimensional checks without any practical distinction for the
N1, N2 or N3 level nuclear pressure equipment.
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When the dimensional requirements are included in the risk analysis, a manufacturer’s report certifies
the value measured and conformity with as-built drawings of the equipment. The aim of this
requirement is to ensure traceability of the most “critical” dimension however it does not challenge the
use of measuring methods such as visual standards if the risk analysis concludes that this type of
method is adapted to the requirements to be met. In this case, the report states the guarantee value and
not the measured value. For other dimensions, a dimensional check certificate drawn up by the
manufacturer is sufficient.
Whenever a manufacturer carries out visual inspections internally prior to the final check, it is not
mandatory to put these results in writing in a report however this is good practice.
The documentation review of the final check supplements the examination of the design and
manufacturing technical documents which, when required must have been assessed at the latest at this
stage. It must be carried out as early as possible and take account of the inspections and examinations
performed during manufacturing (documentation examined during inspection).
Before the end of the final check, the notified body or the operator-specific organisation will ensure
that it has comprehensively assessed all the documentation required by the assessment module applied
and which help to prove compliance of an essential safety requirement, an ERP or a requirement
resulting from highly improbable situations as well as the appropriateness of the instruction manuals.
The documentation review of the final check must include an exhaustive examination by the notified
body or the operator-specific organisation of the following documentation possibly complemented by
other documents identified by the risk analysis which help to prove compliance with the identified
requirements:
 Inspection documents for basic materials and assembly materials;
 Qualifications and approvals of personnel responsible for permanent assemblies;
 Qualifications and approvals of personnel responsible for NDT;
 NDT reports planned by the risk analysis;
 Information on heat treatments;
 Destructive test reports (test samples);
 Non-conformity reports and repair procedures (where appropriate);
 Dimensional check reports provided for by the risk analysis;
 Instruction manual.
The documentation review must also include a sample check of the document helping to prove
compliance of the additional requirements identified in the risk analysis. The notified body must carry
out a sample examination to ensure proof of compliance of the design requirements identified in the
risk analysis for APSRP (case of N1 level nuclear pressure equipment) for example.
If a deviation is detected within the context of this sample examination, the notified body or the
operator-specific organisation will carry out a more thorough inspection.
The exhaustive review by the notified body or the operator-specific organisation of the manufacturer’s
inspection reports does not mandatorily involve detailed check of their content. It is the responsibility
of the notified body or the operator-specific organisation to define the nature of this review and to put
its practices into a procedure.
Except for specific cases related to use of the inspections instead of the visual examination, the
examination of X-ray films or recordings associated with the NDT reports is not required for the final
check but falls under inspection during manufacturing.
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3.9.3
Visual examination
The visual examination must be performed on all external and internal surfaces of equipment for which
essential safety requirements or ERP shall be applied and for which conformity may be visually
inspected. The notified body or the operator-specific organisation will check in advance that the
manufacturer has identified all of these requirements in the risk analysis. The visual examination must
make it possible, among others, to ensure that there are no geometrical or surface condition anomalies.
Adapted methods for checking compliance of the ERP may be implemented provided that the
representativeness of the areas inspected is demonstrated and that these inspections are extended if an
anomaly is detected for:
 Piping equipment,
 The parts of equipment likely to create a risk with regard to pressure resistance (APSRP),
 The “other parts” of equipment as identified in paragraph 3.1.
The visual inspection must be performed after any manufacturing or repair operation (welding, heat
treatment, lining contributing to compliance with an essential requirement, etc.) and before any other
lining is applied. A visual inspection under the final check must be carried out by the notified body or
the operator-specific organisation in the following situations:

Before the pressure resistance test, with the aim of checking conformity of the equipment
with the essential requirements and the equipment’s capacity to withstand the pressure
resistance test. It will be carried out inside and outside to check the general condition of the
equipment, its conformity with the drawings and the condition of the welds;

After the pressure resistance test, to check that there is no damage further to the test and
removal of the temporary devices implemented during the pressure resistance test. The
notified body or the operator-specific organisation will check that the equipment has been
made compliant with the design drawing. This inspection does not necessarily concern all the
internal and external parts of the equipment;

After performing any action likely to affect conformity of the equipment with the
requirements identified by the risk analysis, carried out after the pressure resistance test and
before the end of the equipment conformity assessment while it is under the manufacturer’s
responsibility. The aim of this visual examination is to check that the equipment withstood the
activity without jeopardizing compliance with the requirements identified by the risk analysis.
This may involve activities such as transport, installation (case of assemblies), functional tests
or even the storage conditions. The notified body or the operator-specific organisation may
decide not to examine all the internal and external parts of the equipment in particular
depending on the risk analysis and the proof provided by the manufacturer.

In case of repair following handling of a deviation, another visual inspection of the
relevant zone must be carried out.
The manufacturer must guarantee safe access to the parts subject to the visual examination, sufficient
lighting and must make itself available to the notified body or the operator-specific organisation to
perform any additional inspection such as the dimensional measurements.
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Whenever the internal and external visual inspection mentioned above cannot be performed in its
entirety at the end of manufacture, because the part in question is no longer accessible or because
performing the visual inspection at a final stage of manufacturing may cause significant practical
difficulties, the notified body or the operator-specific organisation can carry it out at an earlier stage of
manufacturing where the parts are visible. The manufacturer must therefore transmit to the notified
body or the operator-specific organisation all the elements required for allowing it to perform the final
check while the parts in question are still accessible.
The manufacturer must demonstrate that the essential safety requirements and the ERP which form the
subject of an early inspection are not likely to be jeopardised during the later manufacturing stages. If
this proof requires implementing specific actions, they must be described in procedures. Based on the
methods defined in an internal procedure, the notified body or the operator-specific organisation
checks proper application of these specific actions and performs sample inspections on the equipment
at an adapted manufacturing stage in order to ascertain that they actually guarantee compliance with the
essential safety requirements and the ERP in question. If an anomaly is detected during this inspection,
the notified body or operator-specific organisation may request an extension of the inspection.
If it is not possible to carry out an inspection, even one in advance, or if there are significant practical
difficulties7 linked with performing the inspection, the manufacturer can suggest to the notified body or
the operator-specific organisation that another inspection supplementing said inspection or replacing it
be carried out. This examination may involve a borescope inspection or any other non-destructive
testing procedure specifically performed or as part of the manufacturing process. The implementation
of replacement methods must be authorised by the notified body or the operator-specific organisation
based on the justifications that they help to provide suitable guarantees equivalent to the visual
inspection.
The results of the inspections replacing or supplementing the visual inspection will be fully reviewed by
the notified body or the operator-specific organisation during the final check. The notified body or the
operator-specific organisation may need to be present during implementation by the manufacturer of
the methods substituting the visual inspection for example in the scope of performing remote
inspections.
If the inspections cannot be carried out in advance or if a replacement method for the visual inspection
cannot be used, the notified body or the operator-specific organisation must examine whether the
situation stems from a design problem and ensure that the requirements related to the equipment
inspection are complied with.
In exceptional cases duly justified by the manufacturer, the notified body or the operator-specific
organisation replaces the visual inspection with reinforced monitoring methods of the manufacturing
so as to provide a supplementary level of guarantee. This monitoring must be carried out in addition to
the normal monitoring and relate to zones whose representativeness is ensured. It must also form the
subject of an inspection plan and must not be restricted to unexpected visits or examinations of zones
for which there are the least performance difficulties. As applicable, the residual risk stemming from
the difficulties in performing the visual inspection must be developed in the instruction manual and
may require checks during service or prior to commissioning.
The equipment for which the safety report of the facility to which they are intended excludes failure,
and referred to as being in “exclusion of failure” cannot form the subject of replacement inspections to
the visual inspection. They must therefore be subject to a comprehensive visual inspection either in
advance or at the end of manufacturing and where necessary by remote technical means.
For piping equipment, the previous principles can be applied as follows:
7
The difficulty in performing the visual inspection is to be assessed based on the technical and practical progress at the time of
manufacture.
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




If the internal visual inspection cannot be carried our during the final assembly stage without
excessive difficulty7, for example in the case of pipe sections assembled on site, this inspection
must be anticipated at the stage prior to prefabrication;
The inspection of the ERP applicable to standard sections of the pipes, in particular those
relating to their internal surface condition may only concern the edges of the pipe sections
(internal parts visible without instruments) provided that the manufacturer justifies in light of
the manufacturing processes that the inspection of only these edges makes it possible to
guarantee compliance with the requirements. The inspections performed on the welds may be
used to supplement the inspection of the pipe edges. If a risk is suspected, this inspection
must be extended;
Remote inspection means for example “borescope” are to be implemented for exhaustive
visual examination of the internal parts of the pipes (main sections and welds) insofar as the
specific EES whose aim is to prevent a damaging mode apply thereto in particular the
requirements related to the risk of thermal fatigue. The zones in “exclusion of failure” are also
subject to an exhaustive visual inspection;
For pipes or pipe sections not provided for in the previous point, in the state of the art or the
state of the practice, compliance with the requirements which apply to the welds may be
subject to a sample check provide that the manufacturer in addition to the final check
promotes NDTs for which it can prove that they help to check compliance with the
requirement in question. In this case, the notified body or the operator-specific organisation
will perform its monitoring according to an inspection plan drawn up in accordance with an
internal procedure based on the following principles:
- The choice of the areas examined is not only based on accessibility of the areas after
prefabrication or start of installation;
- The sampling conditions are defined and drawn up in order to represent the various types
of welds used (processes, positions, etc.) and to meet the minimum inspection
frequencies mentioned in table 3.9.3 below. For the same characteristics, the use of easily
visible areas can of course be given priority;
- The procedure must provide for extension of the inspection in case of anomaly in
particular if the use by the notified body or the operator-specific organisation of other
useful elements for the final check in particular radiographs in highlighting geometric
anomalies on a particular type of weld.
During inspection of the welds, the notified body or the operator-specific organisation will
also ensure that there are no anomalies in the main sections close by.
Table 3.9.3
Welds performed in the
prefabrication workshop
Welds performed on site in
the scope of pipe
manufacture
Applicable requirements
Minimum frequency
Appendix 1 of the order [5]
100% of the welds
Appendix 2 of the order [5]
50% of the welds
Appendix 3 of the order [5]
10% of the welds
Appendix 1 of the order [5]
50% of the welds
Appendix 2 of the order [5]
25% of the welds
Appendix 3 of the order [5]
10% of the welds
The welds of pipes “in exclusion of failure” are fully inspected irrespective of whether they are
performed in the prefabrication workshop or on site in the scope of pipe manufacture.
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3.9.4
Pressure resistance test
The notified body or the operator-specific organisation performs, or has performed, a pressure
resistance test, normally in the form of a hydrostatic pressure test, according to the conditions of point
3.2.2 of appendix 1 of the decree [2].
The notified body or the operator-specific organisation ensures proper preparation of the equipment,
conformity with the safety requirements and proper calibration of the measurement equipment used, in
particular:
 Cleanliness of the equipment subject to pressure resistance test,
 Visibility of the entire external surface of the equipment to be tested,
 As applicable, the water chemistry used for the hydraulic test,
 The use of a direct reading pressure gauge to measure the test pressure, whose scale range
value will be selected close to twice the test pressure, but will under no circumstances be less
than 1.5 times nor greater than 3 times this test pressure,
 The pressure gauge class will be less than or equal to 1 (maximum allowable error over the
range of the scale less than or equal to 1%).
The notified body or the operator-specific organisation will then authorise pressurisation up to the test
value defined according to point 3.2.2 of appendix 1 of the decree [2]. The pressure resistance test is
maintained for the time required to ensure resistance of the equipment and that there is no leakage.
After the pressure resistance test, the notified body or the operator-specific organisation carries out a
visual inspection with the aim of checking that there is no leakage and no visible permanent distortion.
The examination of the walls, performed further to the resistance test, may be carried out at a pressure
lower than the test pressure.
For each pressure resistance test, the notified body or the operator-specific organisation must draw up
a report and the following information must notably be recorded:
 The equipment manufacturer and identification;
 The name of the inspector;
 The test pressure;
 The fluid used for the test if other than water and its temperature;
 The holding time of the test pressure;
 The identification of the test pressure gauges and the scale range value;
 The scope of the visual inspection performed after the pressure resistance test and its
conclusions.
3.9.5
Marking
The marking of equipment must include at least the first three points in section 3.3 a), where necessary
supplemented by the information in 3.3 b), of appendix 1 of the decree [2]. In all cases, the
identification of the equipment must be sufficient so that the associated supporting documents can be
attached. The notified body or the operator-specific organisation will check conformity of the marking.
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3.10.
Monitoring of the final check (modules A1, C1)
The notified body or the operator-specific organisation will carry out monitoring by making
unannounced visits during which it will make sure that:
 Instructions for the final check exist and are implemented;
 The manufacturer correctly performs the final check for each item of equipment built
according to the principles stipulated in paragraph 3.9;
 The correct calibration of the measurement instruments used.
The notified body or the operator-specific organisation attends at least the first final check operation
and will then carry out at least one announced visit every six months. The number of visits may be
increased according to their findings. The manufacturer must inform the notified body or the operatorspecific organisation of when the final checks are to be performed so that it can make an unannounced
visit. This information must include the address of where the monitoring of the final check will take
place.
The notified body or the operator-specific organisation randomly chooses one or more items of
pressure equipment at the manufacturing or storage site for inspection. It will evaluate the number of
items of equipment to be chosen as well as the need for a complete or partial final check on the
equipment. In this case, the notified body or the operator-specific organisation performs, or has
performed, the final check in accordance with the principles indicated for modules F and G (refer to
§ 3.9).
During these unannounced visits, the notified body or the operator-specific organisation examines the
technical documentation concerning the final check indicated in paragraph 3.9 which must be made
available by the manufacturer.
The manufacturer must send the notified body or the operator-specific organisation a list of the
equipment bearing the number of that body or organisation within the context of the order linking the
body or organisation to the manufacturer.
3.10.1 Changes to the types of equipment produced
The manufacturer must inform the notified body or the operator-specific organisation of any changes
or structural modifications to the types of equipment produced in relation to those initially declared. In
this case, the notified body or the operator-specific organisation will assess the impact of these changes
on how the final check is performed and decide what actions should be taken. The notified body or the
operator-specific organisation will take into account:
 The results of previous monitoring visits;
 Understanding of the methods used for the final check.
3.10.2 Management of deviations detected by the notified body or the operatorspecific organisation
A deviation concerning an item of equipment is considered to be satisfactorily dealt with by the
manufacturer:
 If it corrected the deviation noted by implementing the appropriate actions,
 If it analysed the impact on other past, current and future productions and defined and
applied the acceptable corrective measures.
For deviations detected by the notified body or the operator-specific organisation which do not call
into question the conformity of the equipment manufactured in accordance with the requirements of
the order [5], the manufacturer shall take the necessary corrective measures. Depending on the nature
and significance of these deviations, the notified body or the operator-specific organisation can increase
the frequency of unannounced visits.
For deviations likely to call into question compliance with the requirements of the order [5], the
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notified body or the operator-specific organisation will ask the manufacturer to describe the solutions it
intends to adopt to remedy the deviations and will validate them before implementation. To ensure that
these solutions are adopted the notified body or the operator-specific organisation must increase the
frequency of unannounced visits. If the deviations persist or if compliance with the requirements
cannot be ensured, the notified body or the operator-specific organisation states this and advises ASN
accordingly.
3.11.
Type examination (module B)
The manufacturer will provide the notified body with at least one representative sample of production,
referred to as the type, accompanied by the general description of the type indicated in § 2.4.1, the
technical documentation described in § 2.4.2 and the tests provided for within the scope of
manufacturing.
The notified body will perform or have performed the appropriate inspections and tests required for
checking whether the solutions adopted by the manufacturer meet the requirements stemming from the
risk analysis.
The notified body will at least:
 check that the type was manufactured in compliance with the technical documentation;
 check the provisions of paragraph 3.7 with regard to the manufacturing processes;
 check the relevance of the NDTs and corresponding reports as well as the radiographs;
 perform or have additional NDTs performed in case of doubts;
 check the results of destructive tests;
 perform or have additional destructive tests performed in case of doubts;
 carry out a visual inspection according to the principles mentioned in paragraph 3.9.3;
 perform a functional check of the closure, opening, filling and draining devices and safety
accessories;
 carry out a hydraulic resistance test on the equipment or have it carried out.
3.12.
Type-examination certificate or design-examination certificate (module B,
B1)
3.12.1 Issuing of the certificate
When the type or the equipment subject to the design examination meets the corresponding
requirements of the order [5], the notified body grants the applicant a type-examination certificate or
design-examination certificate. This certificate contains the conclusions of the inspection and
identification of the type and permitted versions. It includes the list of relevant parts of the technical
documentation. The validity period of the type-examination certificate is 10 years renewable from the
issue date.
3.12.2 Refusal to issue the certificate
When the type or equipment subject to the design examination does not meet the corresponding
requirements of the order [5], the notified body does not issue the certificate. It gives the applicant
detailed reasons for its refusal.
3.12.3 Supplement to a type-examination certificate or design-examination certificate
The applicant must inform the notified body of any modifications made to the approved pressure
equipment referred to in the certificate. These modifications must form the subject of a new approval if
they are liable to affect the conformity of the pressure equipment with the requirements of the order [5]
or the intended operating conditions. This new approval does not necessarily require all the
examinations that were initially conducted to be repeated. If this new approval is satisfactory, the
notified body then issues a supplement to the initial certificate.
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3.12.4 Renewal of a type-examination certificate
After 10 years of validity, the notified body that issued the type-examination certificate and that holds
the technical documentation may at the request of the manufacturer or its representative, renew the
type-examination certificate for a further 10-year period, provided that the type has not undergone any
modifications likely to affect the conformity of the equipment with respect to the requirements of the
order [5]. Otherwise, the notified body does not renew the certificate and advises the applicant
accordingly.
3.13.
Identification of the notified body or the operator-specific organisation
The notified body will affix its identification number or have it affixed following a satisfactory
assessment for all the modules excluding quality assurance except modules B and B1. The operatorspecific organisation will affix its stamp or have it affixed for modules A1, C1, F and G.
4.
WORK TO BE PERFORMED AS PART OF THE CONFORMITY
ASSESSMENT OF ASSEMBLIES
4.1.
Data provided by the assembly manufacturer or the operator
Whenever the manufacturer of the assembly describes, for each item of equipment or intermediate
assembly, the data provided by the operator in consistency with the safety report as stipulated in § 2.4.2,
the notified body or the operator-specific organisation examines the consistency of the situations and
loads of each item of equipment or intermediate assembly with those provided for the assembly by the
operator.
This check is carried out for all items of equipment composing the assembly even when the assembly
manufacturer has only given the situations and loads for a part of the equipment. ASN will assess the
consistency of the data provided by the operator with the facility safety report.
4.2.
Risk analysis
The notified body or the operator-specific organisation will check for the assemblies, as well as for each
item of equipment whose conformity is assessed as part of the assembly, that the risk analysis complies
with the criteria in paragraph 3.1.
Moreover, the notified body or the operator-specific organisation will check that the risk analysis of the
assembly takes account of the set of instruction manuals for the intermediate assemblies or equipment
composing the final assembly.
4.3.
Design assessment
The notified body or the operator-specific organisation will check that the assemblies are designed so
that the items to be assembled are adapted and reliable in their operating conditions and that all
components are integrated and assembled properly. The notified body or the operator-specific
organisation will check that:
 The components to be assembled are suitable for their operating conditions (operating
pressure, operating temperature, type of fluid, loads, breakdown of the unstable fluids, etc.)
and for other situations specified by the operator or the assembly manufacturer;
 All components are integrated and assembled properly;
 The overpressure protection is suitable.
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The notified body or the operator-specific organisation will rely on the technical documentation for the
final assembly specified in § 2.4.2 to check that the information is appropriate in relation to:
 The assembly design (operating pressure, operating temperature, fluids, nozzle forces, content
of explosive fluid, breakdown of unstable fluids, etc.);
 Compatibility of materials;
 Radiation protection;
 Dimensional compatibility;
 operating conditions:
- Consistency and interactions between the various items of equipment including category
0 equipment or equipment not subject to assessment;
- Access prohibited as long as the fluid pressure or temperature is dangerous;
- Risks related to filling and draining;
- Closure and opening devices;
- Risks related to hazardous emissions from the safety devices and accessories.
 In-service maintenance and inspection methods.
4.4.
Conformity assessment of each item of equipment or intermediate
assembly
The conformity of category I to IV equipment or intermediate assemblies composing the final assembly
can be assessed as part of the conformity assessment of the assembly. Each item of equipment or
intermediate assembly thus assessed form the subject of a declaration of conformity and a certificate of
conformity according to the modules applied.
In other cases, the conformity assessment of equipment or intermediate assemblies must be completed
before they are installed in the assembly. The notified body or the operator-specific organisation
responsible for assessing the conformity of the final assembly must receive the certificates and
declarations of conformity as well as the instruction manual for these equipment or intermediate
assemblies at the latest before their installation begins.
In duly justified exceptional cases, the manufacturer of the final assembly may apply to the notified
body or the operator-specific organisation responsible for its conformity assessment in order to
examine the possibility of installing equipment or intermediate assemblies assessed individually before
the end of their conformity assessment.
In this case, the manufacturer of the final assembly will have to provide written proof of why it is
impossible to install the equipment or intermediate assemblies in question after their assessment. It will
propose measures making it possible to ensure compliance with the applicable requirements and proper
implementation of the conformity assessment procedures for the equipment and assemblies. This
application must where possible be made before the application for conformity assessment of the
equipment and assemblies in question.
In such situations, manufacturers of the equipment or intermediate assembly, the final assembly
manufacturers and the bodies and organisations responsible for their conformity assessment must give
their prior approval, after guaranteeing that all the technical and documentary items required for
carrying out integration of the equipment or intermediate assembly are available.
The notified body or the operator-specific organisation responsible for assessing conformity of the
final assembly will ensure that the application of the final assembly manufacturer is justified and that, as
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required, the stakeholders have given their prior approval. The notified body responsible for
conformity assessment of the equipment or intermediate assembly must be associated with the process
until it can issue the certificate of conformity for the equipment or intermediate assembly.
The equipment or intermediate assemblies composing the final assembly must also be designed and
manufactured in accordance with different building codes. For the items of equipment or the
intermediate assembly whose conformity was assessed individually, the conformity assessment was able
to be carried out according to different modules and by different bodies or organisations. The
manufacturer of the final assembly must take all necessary measures so that the notified body or the
operator-specific organisation is provided with all the information on the equipment and intermediate
assemblies that it needs to assess conformity of the final assembly. If necessary, the notified body or the
operator-specific organisation responsible for conformity assessment of the final assembly must have
access to all or part of the technical documentation used for conformity assessment of the individually
assessed equipment or intermediate assemblies.
4.5.
Changes to equipment or intermediate assemblies
When the manufacturer of the final assembly performs an operation likely to have an effect on an
essential safety or radiation protection requirement on an item of equipment or an intermediate
assembly that is not assessed within the context of the assembly, or if said operation results in
exceeding the limits stipulated by the instruction manual, a new conformity assessment of the modified
item of equipment or intermediate assembly must be carried out as part of assessing conformity of the
final assembly. The notified body or the operator-specific organisation must receive from the assembly
manufacturer the technical documentation required for this new conformity assessment of the modified
equipment.
Provided that the manufacturer complies with the provisions stipulated by the instruction manuals, this
provision does not apply to operations assessed within the scope of the conformity assessment of the
final assembly for example connection of two items of equipment that were previously assessed. The
notified body or the operator-specific organisation performs its work according to the conformity
assessment procedure for assembly installation operations (refer to paragraph 4.6).
4.6.
4.6.1
Actions during installation activities
Actions during building of assemblies
The building of assemblies includes actions which are intended to couple the equipment or
intermediate assemblies composing the final assembly as well as any heat treatment and non-destructive
testing related thereto.
The notified body or the operator-specific organisation will assess the conformity of the assembling of
pressure equipment or intermediate assemblies together in accordance with the requirements and the
conformity assessment procedure determined by the highest level and category of equipment in
question. Different conformity assessment modules can be used for the different assemblies.
The notified body or the operator-specific organisation will carry out monitoring of assemblies
according to an inspection plan drawn up in accordance with an internal procedure based on the
assembly manufacturer’s risk analysis.
In the case of an assembly comprising at least N1 level category I to IV item of equipment subject to
the requirements of appendix 1 of the order [5], this procedure will be submitted to ASN beforehand.
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Should the manufacturer select several modules for assessing the conformity of the assemblings, the
notified body or the operator-specific organisation draws up an inspection plan for each module in
accordance with the aforementioned internal procedure.
4.6.2
Actions during other installation operations
The notified body or the operator-specific organisation will rely on the technical documentation for the
final assembly including the instruction manuals of the equipment or intermediate assemblies
composing the final assembly in order to check compliance with the requirements applicable to the
assembly in installation conditions other than the building of assemblies.
This may involve operations such as supporting and securing the equipment, installation of lining or
insulators, performance of inspections or tests as well as transport. The impact of the storage
conditions must also be taken into consideration.
The notified body or the operator-specific organisation will carry out monitoring of the installation
operations according to an inspection plan drawn up in accordance with an internal procedure based on
the assembly manufacturer’s risk analysis. This procedure is submitted to ASN beforehand in the case
of an assembly composing at least one N1 level category I to IV item of equipment subject to the
requirements of appendix 1 of the order [5].
4.6.3
Data required for drawing up the inspection plans
The notified body or the operator-specific organisation will ensure before the start of the installation
operations that it has received all the information required for drawing up its inspection plans in
accordance with the principles outlined in paragraph 3.7.1.
4.7.
Assessment of the protection against exceeding the allowable service
limits
The notified body or the operator-specific organisation will assess the conformity of the protection of
the assembly against exceeding of the allowable service limits in accordance with the requirements of
points 2.10 and 2.11 of appendix 1 of the decree [2] and based on the conformity assessment procedure
determined by the highest level and category of equipment to be protected. The triggering flowrates
and thresholds or the set pressure of the safety accessories limiting the pressure must help to comply
with the requirements of appendix 1 of the decree [2] as well as of the order [7].
The notified body or the operator-specific organisation will rely on the technical document of the final
assembly and on the instruction manuals for the equipment or intermediate assemblies which make up
the final assembly to check compliance with the applicable requirements.
4.8.
Final check
The principles of the final check for the nuclear pressure equipment stipulated in paragraph 3.9 apply
to the final check of the assembly.
During the final check of the assembly, a check to determine whether there are one or more safety
devices for all the reasonably foreseeable situations which may cause overpressure is carried out in
accordance with point 2.10 of appendix 1 of the decree [2].
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A new visual inspection under the final check is required as long as any operation likely to have an
impact on the conformity of the assembly with the requirements identified in the risk analysis is carried
out after the pressure resistance test. This may involve for example examining the condition of
supports following a functional test. In this case, the notified body or the operator-specific organisation
will inform the manufacturer of the parts of the assembly for which the insulator needs to be removed.
In accordance with Article 12 d) of the order [5], the assemblies must undergo a pressure resistance test
as defined in point 3.2.2 of appendix 1 of the decree [2]. This requirement must be taken into account
by the assembly manufacturer from the design stage. Accordingly, each item of equipment or
intermediate assembly whose conformity is assessed as part of the conformity assessment of the final
assembly must undergo a pressure resistance test in the same way as if it was assessed individually.
Moreover, a pressure resistance test must be carried out on the final assembly covering all the
permanent assemblies in accordance with point 3.2.2 of appendix 1 of the decree [2]. If the hydrostatic
pressure test is damaging or if it cannot be performed despite the measures taken upon design, it can be
replaced with other test of a recognised value with the additional measures mentioned in point 3.2.2 of
appendix 1 of the decree [2].
4.9.
Marking
The marking of the assembly must include at least information in the first three points in 3.3 a) of
appendix 1 of the decree [2], and where necessary supplemented by the information in section 3.3 b). In
all cases, the identification of the assembly must be sufficient so that the associated supporting
documents can be easily attached.
The marking on the assembly must be affixed:
 On a single plate,
 On one of the main equipment items or in a location of this assembly that is accessible and
visible and which does not entail any specific risk.
The notified body or the operator-specific organisation will check conformity of the marking and that
the location of the marking is indicated in the instruction manual of the assembly.
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5.
ASSESSMENT WORK PERFORMED ACCORDING TO THE
MODULES WITH QUALITY ASSURANCE (D, D1, E, E1, H, H1)
5.1.
Initial assessment of a quality system (modules D and D1)
The operator-specific organisation must be provided with the procedures concerning the organisation
of the initial assessment of the quality system as well as the decision-making criteria and the processes
used to decide on whether to approve or reject the quality system.
The assessment of the quality system includes:


An initial audit based on standard NF EN ISO 9001 with the exclusions authorised by the
standard for module D (refer to § 7.3), taking account of certification prior to the standard or
to an equivalent reference system and the provisions of appendix 2 of the decree [2] applicable
to the selected module (point 3.2 of module D, and 4.2 of module D1);
An inspection of the manufacturer’s manufacturing, final check, testing and storage facilities.
The notified body will formalise justification of the selection of the premises visited.
If the manufacturer subcontracts all or part of the manufacture, the manufacturer’s quality system must
guarantee compliance with the “production quality” requirements through the application of one or
more procedures defining the subcontracting conditions. In this case, the notified body also carries out
inspection visits on the facilities of the main subcontractors.
During the inspection of the premises, the notified body examines the quality documents mentioned in
paragraph 2.4.3 and inspects the production means in order to check:











The document in which the manufacturer has listed the production facilities intended to be
used;
The traceability and conformity of the materials supplied;
The use and implementation of qualified, and if necessary approved, permanent assembly
procedures;
The compatibility between the qualifications and if necessary approvals of the personnel
responsible for permanent assemblies and the work performed;
Compliance with the manufacturing and inspection procedures described in the quality
system;
The compatibility between the qualifications and if necessary approvals of the personnel
responsible for performing inspections and tests;
The correct calibration of the measuring instruments used;
The keeping of records of production, inspection, test and examination data;
The traceability of final checks (final examinations and testing);
That the final check, if applicable, includes the examination of each of the safety devices
installed;
The conformity of the planned marking, including indication of the manufacturing and service
marks and the content of the declaration of conformity to be issued.
Note: when module D is used, the manufacturer must already have a type or design certificate.
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5.2.
Initial assessment of a quality system (modules E and E1)
The assessment is similar to that described in 5.1, with the exclusions authorised by standard
NF EN ISO 9001 for module E. The inspection visit however only concerns the final check, testing
and storage facilities.
Note: when module E is used, the manufacturer must already have a type certificate.
5.3.
Initial assessment of a quality system (modules H and H1)
The notified body must receive the procedures regarding organisation of the initial assessment of the
quality system as well as the decision-making criteria and the process helping to decide on whether to
approve or refuse the quality system.
The assessment of the quality system involves:


An initial audit based on standard NF EN ISO 9001, taking account of a certification prior to
standard NF EN ISO 9001 or to an equivalent reference system and the provisions of
appendix 2 of the decree [2] applicable to the selected module (point 3.2 of module H);
An inspection visit of the manufacturing, final check, testing and storage facilities. The
notified body formalises the reasons for choosing the premises visited.
If the manufacturer subcontracts all or part of the manufacture, the notified body will also carry out its
inspection visits on the facilities of the main subcontractors.
During the installation inspection, the notified body examines the quality documents stipulated in
paragraph 2.4.3 and inspects the production facilities in order to check:


The points mentioned in paragraph 5.1,
Compliance of the design and the design checking procedures used to ensure that the
requirements of the order [5] are met.
When modules G+H (see table in paragraph 2.2) are applied, the notified body advises ASN of the
chosen dates for carrying out this assessment.
5.4.
Monitoring the quality system (modules D, D1, E, E1, H, H1)
The notified body must receive the procedures regarding organisation of the quality system monitoring
as well as the decision-making process and criteria used to decide whether to maintain or withdraw
approval of the quality system.
The notified body ensures that the manufacturer properly fulfils the obligations of the quality system
that it approved through monitoring of the quality system which includes:
 Periodic audits;
 Unannounced visits.
The manufacturer periodically advises the notified body of its planned production schedule and each
year sends the notified body a review of the equipment produced bearing the number of the notified
body.
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When modules G+H (see table of paragraph 2.2) are applied:



The notified body advises ASN of the dates selected for the periodic audits;
The periodic audits do not include the supervision of a final check;
If the same notified body is responsible for application of modules H and G, it may take
account of the monitoring performed under module G to define unannounced inspections.
5.4.1
Periodic audits
Periodic audits to monitor the quality system are conducted on request from the notified body in order
to ensure that the manufacturer maintains and applies its quality system.
The frequency and scope of the periodic audits must enable a complete reassessment of the quality
system at least every three years. Periodic audits are therefore performed at least once per year.
They cover first and foremost the assessments of the points which were the subject of observations
during previous audits or unannounced inspections and the modifications of the quality system.
The periodic audit (not including application of modules G+H), includes, if possible, and at least once
every three years, the supervision of a final check (final examination, testing, assessment of
documentation, examination of safety devices in the case of assemblies). The notified body therefore
assesses whether the manufacturer has performed the final check according to the principles outlined in
§ 3.9.
5.4.2
Unannounced inspections
Every year, the notified body will carry out unannounced inspections in addition to the periodic audits.
These inspections are scheduled according to an internal procedure to the notified body which takes
account of:
 The level of category of the equipment;
 The results of periodic audits or previous periodic inspections and especially the nature of the
deviations detected;
 The need to track the corrective measures;
 The special conditions associated with approval of the system;
 The significant changes in the organisation of manufacture, measurements or techniques.
At least two unannounced inspections must be carried out per year.
During unannounced inspections, the notified body may perform or have performed all the tests it
deems necessary to check the satisfactory operation of the quality system. It may also choose to
perform monitoring of the final check which it carries out as indicated in paragraph 5.7 for module H1.
It also checks that the equipment manufactured is covered by the approval of the quality system.
The manufacturer must inform the notified body or operator-specific organisation of the periods when
the final checks are to be performed so that they can make an unannounced visit. This information
must include the address of where the monitoring of the final check will take place.
5.4.3
Management of deviations detected by the notified body
For deviations detected by the notified body that do not call into question the conformity of equipment
manufactured in relation to the requirements of the order [5], the notified body will ask the
manufacturer to take the necessary measures to correct the deviations noted. Depending on the nature
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and significance of these deviations, the notified body may increase the frequency of audits and
unannounced inspections.
For deviations likely to call into question compliance with the requirements of the order [5], the
notified body will ask the manufacturer to describe the solutions it intends to adopt to remedy the
deviations and validates them before they are implemented. If compliance with the requirements
cannot be ensured, the notified body will state this and will advise ASN accordingly.
In order to ensure the solutions are implemented, the notified body carries out intensified monitoring.
If the deviations persist, the notified body withdraws its approval of the quality system and advises
ASN accordingly. The manufacturer is notified by registered letter with acknowledgement of receipt.
A deviation concerning an item of equipment or the quality assurance system is considered as properly
dealt with by the manufacturer if:
 It has corrected the deviation noted by implementing the appropriate actions,
 If it has analysed the impact on the other past, current and future productions performed in
the scope of the approved quality system and has defined and applied the acceptable
corrective measures.
5.5.
Specific assessment of the quality system (modules D, D1, E, E1, H, H1)
5.5.1 Modification of the quality system or the production facilities
The manufacturer is required to inform the notified body of any plan to adjust or modify the quality
system and its production facilities. The notified body will evaluate the impact of these modifications
on the quality system that was initially approved and decide whether to accept them or have them
reassessed.
5.5.2
Change in the scope of the assessment application
The manufacturer is required to advise the notified body of any change with regard to the generic
group (family, type, version) of pressure equipment that was previously approved. In this case, the
notified body will carry out a new assessment of the quality system.
The procedures for this new assessment may not include all the checks listed in paragraphs 5.1, 5.2 and
5.3. The new assessment may require specific monitoring of the first items of new equipment
concerned.
5.6.
5.6.1
Notification of decisions following quality system assessment (modules D,
D1, E, E1, H, H1)
Initial audit
The manufacturer is informed of the findings at the end of the initial audit so that it can process them.
The manufacturer is informed in writing of the decision to approve the quality system after the initial
audit. The decision is valid as long as the notified body considers that it has the means to ensure
through a complete reassessment of the quality system over a maximum period of 3 years, that the
manufacturer maintains and applies its quality system. The date of approval of the quality system
following the initial audit cannot, as applicable, precede the date for raising non-conformities. If a
period of validity for the approval is defined, the manufacturer is responsible for taking the necessary
measures so that the approval of its quality system is renewed before the expiry date.
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In the event of refusal, the manufacturer is informed of the decision by registered letter with
acknowledgement of receipt. This notification contains the conclusions of the audit as well as any
restrictive clauses.
The procedure is identical for any changes to the quality system.
5.6.2
Monitoring
The reports of monitoring operations are sent to the manufacturer. The manufacturer is informed of a
decision to withdraw the approval of the quality system by registered letter with acknowledgement of
receipt if the notified body considers that it does not have the means to ensure over a maximum period
of three years that the manufacturer maintains and applies its quality system or if the conclusions of the
monitoring operations so require.
5.6.3
Information
Each notified body informs the other bodies and ASN of approvals that it has withdrawn or refused.
5.7.
Design examination certificate and special monitoring of the final check
(module H1)
The notified body carries out the design examination and issues the design examination certificate
under the same conditions as for module B1.
Moreover, the notified body will mandatorily perform monitoring of the final check during certain
unannounced inspections performed as part of monitoring the quality system (refer to paragraph 5.4.2).
During the unannounced inspections concerning the final check, the notified body will:





Make sure that the instructions for the final check exist and are implemented;
Make sure that the manufacturer performs the final check for each item of equipment
according to the principles stipulated in paragraph 3.9;
Check the correct calibration of the measurement instruments used;
Examine the technical documentation stipulated in paragraph 2.4.2 which must be made
available by the manufacturer;
Choose one or more items of pressure equipment at the manufacturing or storage site for
inspection. It will carry out a complete or partial final check on the equipment in accordance
with the principles mentioned in paragraph 3.9.
The manufacturer must inform the notified body or the operator-specific organisation of the periods
when the final checks are to be performed so that they can make unannounced inspections. This
information must include the address of where the monitoring of the final check will take place.
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APPENDIX 1:
RULES FOR
EQUIPMENT
CLASSIFYING
NUCLEAR
PRESSURE
Refer to table 6.1 below as well as figures 1 to 8 of this appendix in order to determine the risk category
of the various types of N1, N2 or N3 nuclear pressure equipment depending on the nature of the fluids
that they contain.
Table 6.1
Levels N1 and N2
Nature of the fluid
Gas
Liquid
Safety accessories
(1)
IV
Pressure accessories
or containers (2)
Pressure pipes or
accessories (2)
Levels N3
Gas
Liquid
Group 1
Group 2
Group 1
Group 2
IV
IV
IV
IV
IV
Refer to figure 1
Refer to figure 3
Refer to figure 1
Refer to figure 2
Refer to figure 3
Refer to figure 4
Refer to figure 5
Refer to figure 7
Refer to figure 5
Refer to figure 6
Refer to figure 7
Refer to figure 8
(1)
: Category IV except for accessories manufactured for specific equipment which may then be classified in the same category
as the equipment to be protected.
(2)
: Pressure accessory according to the characteristic used: nominal diameter DN or volume V.
Figure 1:
Containers mentioned in point 1(a), first hyphen, in Article 3 of the decree [5]. Exceptionally,
containers designed to contain unstable gases that would normally be in categories I or II on the basis
of the table above must be classified in category III.
Figure 2:
Containers mentioned in point 1(a), second hyphen, in Article 3 of the decree [5].
Figure 3:
Containers mentioned in point 1(b), first hyphen, in Article 3 of the decree [5].
Figure 4:
Containers mentioned in point 1(b), second hyphen, in Article 3 of the decree [5].
Figure 5:
Pipes mentioned in point 3(a), first hyphen, in Article 3 of the decree [5]. Exceptionally, pipes designed
to contain unstable gases that would normally be in categories I or II on the basis of the table above
must be classified in category III.
Figure 6:
Pipes mentioned in point 3(a), second hyphen, of Article 3 of the decree [5]. Exceptionally, pipes
designed to contain fluids at a temperature above 350°C and that would normally be in category II on
the basis of the table above must be classified in category III.
Figure 7
Pipes mentioned in point 3(b), first hyphen, in Article 3 of the decree [5].
Figure 8
Pipes mentioned in point 3(b), second hyphen, in Article 3 of the decree [5].
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Category 0
OUTSIDE ORDER
Figure 1 – Containers containing Group 1 “gases”:
The term “gas” refers to:
-
Gases;
Liquefied gases;
Gases dissolved under pressure;
Vapours;
Liquids whose vapour pressure at the maximum allowable temperature is higher than
0.05 MPa (0.5 bar) at normal atmospheric pressure (1,013 mbar).
Note: Exceptionally, containers designed to contain unstable gases and classified under Category I or II
must be classified in Category III.
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Category 0
OUTSIDE ORDER
Figure 2 - Containers containing Group 2 “gases”:
The term “gas” refers to:
-
Gases,
Liquefied gases,
Gases dissolved under pressure,
Vapours,
Liquids whose vapour pressure at the maximum allowable temperature is higher than
0.05 MPa (0.5 bar) at normal atmospheric pressure (1013 mbar).
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Category 0
OUTSIDE ORDER
Figure 3 – Containers containing Group 1 “liquids”:
The term “liquid” refers to: liquids whose vapour pressure at the maximum allowable temperature is
less than or equal to 0.05 MPa (0.5 bar) above the normal atmospheric pressure (1,013 mbar).
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Category
OUTSIDE ORDER
Figure 4 - Containers containing Group 2 “liquids”:
The term “liquid” refers to: liquids whose vapour pressure at the maximum allowable temperature is
less than or equal to 0.05 MPa (0.5 bar) above the normal atmospheric pressure (1,013 mbar).
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Category 0
OUTSIDE ORDER
Figure 5: Pipes designed for gases, liquefied gases, gases dissolved under pressure, vapours and liquids
whose vapour pressure at the maximum allowable temperature is greater than 0.5 bar at the normal
atmospheric pressure (1,013 mbar), for Group 1 fluids when the nominal diameter DN is greater
than 25.
Exceptionally, pipes designed to contain unstable gases that would normally be in categories I or II, on
the basis of table 1 must be classified in category III.
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Category 0
OUTSIDE ORDER
Figure 6: Pipes designed for gases, liquefied gases, gases dissolved under pressure, vapours and liquids
whose vapour pressure at the maximum allowable temperature is greater than 0.5 bar at the normal
atmospheric pressure (1,013 mbar), for Group 2 fluids when the nominal diameter DN is greater
than 32 and the operating pressure PS multiplied by DN is greater than 1,000 bar.
Exceptionally, pipes designed to contain fluids at temperatures above 350°C that would normally be in
category II, on the basis of table 2 must be classified in category III.
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Category 0
OUTSIDE ORDER
Figure 7: Pipes designed for liquids whose vapour pressure at the maximum allowable temperature is
less than or equal to 0.5 bar above the normal atmospheric pressure (1,013 mbar), for Group 1 fluids
when the nominal diameter DN is greater than 25 and the operating pressure PS multiplied by
DN is greater than 2,000 bar.
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Category 0
OUTSIDE ORDER
Figure 8: Pipes designed for liquids whose vapour pressure at the maximum allowable temperature is
less than or equal to 0.5 bar above the normal atmospheric pressure (1,013 mbar), for Group 2 fluids
when the operating pressure PS is greater than 10 bar and the nominal diameter DN is greater
than 200, and PS multiplied by DN is greater than 5,000 bar.
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APPENDIX 2:
Summary of actions performed by the notified bodies or operator-specific organisations
Conformity assessment procedures
DESIGN AND MANUFACTURING
A1
B
B1
C1
D
D1
E
E1
F
G
H
H1
To be
performed
according
to:
Risk analysis
§ 3.1
X
X
X
X(2)
X
Equipment design
§ 3.2
X
X
X
X(2)
X
Material assessment
§ 3.3
X(1)
X
X(3)
QMOAP
§ 3.4
X(1)
QPAP
§ 3.5
Qualification of NDT personnel
X(1)
X(2)
X(2)
X(2)
X(2)
X
X
X(2)
X(1+2)
X
X(1)
X(2)
X(2)
X(2)
X(2)
X
X
X(2)
X(1+2)
X(1)
X
X(1)
X(2)
X(2)
X(2)
X(2)
X
X
X(2)
X(1+2)
§ 3.6
X(1)
X
X(1)
X(2)
X(2)
X(2)
X(2)
X
X
X(2)
X(1+2)
Involvement during manufacturing
§ 3.7
X(1)
X
X(1)
X
X
Instruction manuals
§ 3.8
X(1)
X
Perform or have performed the final check
§ 3.9
§ 3.11
§ 3.10
§ 5.7
X(1)
X
X(1)
X(2)
X(2)
X(2)
X(2)
X
X
X(2)
X(2)
X(2)
X(2)
X(2)
X
X
X(2)
X
X(1)
X(1+2)
Type examination
§ 3.11
Identification of the notified body
§ 3.13
X
Identification of the operator-specific
organisation
§ 3.13
X
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X
X(1+2)
X
X
X
X
X
X
X
X
X
X
X
X
-
X
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Summary of actions performed by the notified bodies or operator-specific organisations
(cont’d)
Conformity assessment procedures
A1
B
B1
C1
D
D1
E
E1
F
G
X
X
H
H1
CERTIFICATES
Certificate of conformity
§ 2.7
Certificate of type or design examination
§ 3.12
X
X
X
QUALITY SYSTEM
§ 5.1
Initial assessment of the quality system
X
X
§ 5.2
X
X
§ 5.3
X
X
Monitoring of the quality system (periodic audits
and unannounced inspections)
§ 5.4
X
X
X
X
X
X
Specific assessment of the quality system
§ 5.5
X
X
X
X
X
X
Notification of decisions
§ 5.6
X
X
X
X
X
X
X
: Actions carried out by the notified body.
(1): within the context of the actions performed by the notified body or operator-specific organisation during monitoring of the manufacturer’s final check (unannounced inspections).
(2): notified body’s actions used as support for assessment of the manufacturer’s quality system assessment performed during monitoring of the quality system.
(3): according to § 3.3.2 only. Assessment of the nuclear pressure equipment with regard to the design data
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Summary of actions performed by the notified bodies or operator-specific organisations
(cont’d)
ASSEMBLIES
Data supplied by the operator or the assembly
manufacturer
§ 4.1
X
Risk analysis
§ 4.2
X
Assembly design
§ 4.3
X
Equipment or intermediate assemblies assessed
within the context of the assembly
§ 4.4
X
Changes to equipment or intermediate assemblies
§ 4.5
X
Actions during installation activities
§ 4.6
X
Protection against exceeding the allowable limits
§ 4.7
X
Final check
§ 4.8
X
Marking of the assembly
§ 4.9
X
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APPENDIX 3:
Standard content of an instruction manual
GENERAL
 Description of the equipment/assembly and nuclear pressure equipment composing the
assembly
 Operation of the equipment/assembly
 Fluids including for maintenance and cleaning
INSTALLATION OF THE EQUIPMENT/ASSEMBLY
 Storage and preservation (humidity, protection, etc.), before commissioning or during
downtime
 Transport and handling (packaging, protection, anchoring points, sensitive areas, cleanliness,
removal of protection)
 Space required for the installation, handling requirements and adapted machinery
 Location (distance with respect to other objects, access, inspection feasibility, etc.)
 Foundations, constraints and positioning of the supports
 Assembly conditions between equipment items (welding, bolting) and information regarding
integration (geometric compatibility, weldability, tightening torques and instruction,
disconnecting load sets)
 Condition of the installation on which the equipment must be installed (drained systems, dry
system, cleanliness, etc.)
 Actions that can be carried out as part of installation which do not threaten conformity
 Protection against external aggressions on site
 Risks which may result in foreseeable improper use
 Other residual risks to be taken into account





COMMISSIONING
Checks before commissioning
Commissioning procedure (filling and draining points, appropriate quantity of fluid,
pressurisation and heating operations, points to be monitored, etc.)
Risks which may result in foreseeable improper use,
Radiation protection system
Other residual risks to be taken into account
USE
Design bases and safe service limit:
 Situations taken into account upon design
 Code, design conditions, welding joint coefficient, corrosion overthickness,
 Allowable minimum/maximum limits (pressure, temperature, etc.)
 Level monitoring
 Maximum fluid mass
 Insulating casing, vitrified linings
 Specific operating and restarting procedures depending on the various causes of interruption
 Filling (starting, make-up) and draining
 Control and safety devices
 Nature of hazardous products for the equipment
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 Risks which may result in foreseeable improper use,
 Radiation protection system
 Other instructions relating to safe service limits
Important design characteristics for service life
 Creep resistance: forecast service life
 Fatigue resistance: number of cycles taken into account upon design
 Corrosion resistance: corrosion overthickness planned upon design,
 Abrasion resistance: precautions of use and limit thicknesses, etching of the linings,
 Erosion resistance: precautions of use and limit thicknesses, etching of the linings,
 Irradiation resistance (case of reactor pressure vessels): creep or forecast service life,
monitoring
 Record of operating parameters
 Other instructions relating to important design characteristics for the service life
MAINTENANCE – IN-SERVICE INSPECTION
 Maintenance and cleaning precautions in light of knowledge available during drafting of the
manual
 Check and calibration of inspection and control devices and safety accessories (nature,
frequency)
 Check of linings
 Other points subject to monitoring (leakage, etc.)
 Elements to be taken into account for the inspections to be performed on the equipment
(areas, number of welds to be inspected, any recommendations for the inspection
instruments and equipment and the implementation frequency, etc.)
 Risks which may result in foreseeable improper use
 Radiation protection system
 Removable parts, disassembly, possible access to perform inspections,
 Lists, references, characteristics of the replaceable components likely to suffer foreseeable
wear (connections, joints, etc.) or used components (oil, grease, etc.) and the procedures to
be implemented for replacing these parts
 References, characteristics of protections and linings likely to be replaced (insulator, etc.)
 Other residual risks to be taken into account
DOCUMENTATION, DRAWINGS AND DIAGRAMS
EXPLAINING THESE INSTRUCTIONS
 Documentation, drawings and diagrams appended to this manual
MARKING – IDENTIFICATION
 Content and meaning of the marking elements:
 Warning to be affixed
 Preservation of the marking
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COMPENDIUM OF ASN GUIDELINES
No.1
Permanent storage of radioactive waste in deep geological formation
No.2
Transport of radioactive material in airport zone
No.3
Recommendations for drawing up the annual reports for public information regarding
licensed nuclear facilities
No.4
Self-assessment of the risks incurred by patients in external radiotherapy
No.5
Management of the safety and quality of radiotherapy care
No.6
Decommissioning, dismantling and declassification of licensed nuclear facilities in France
No.7
Approval request for shipment and approval of the packaging models or radioactive
materials for civil use transported on the public thoroughfare
No.8
Conformity assessment of nuclear pressure equipment
No.10
Local involvement of CLIs in the 3rd ten-year visit of 900 MWe reactors
No.11
Declaration and coding of criteria relating to significant events in the field of radiation
protection (excluding INB and transport of radioactive materials)
No.12
Declaration and coding of criteria relating to significant events involving safety, radiation
protection or the environment applicable to INB and to transport of radioactive materials
No.13
Protection of licensed nuclear facilities against external flooding
No.14
Full sanitation methodologies acceptable in the licensed nuclear facilities in France
No.15
Safety management policy in the INBs
No.16
Significant radiation protection event for patients in radiation therapy: declaration and
classification on the ASN-SFRO scale
No.18
Disposal of effluents and waste contaminated by radionuclides produced in the facilities
authorised under the French Public Health Code
FRENCH NUCLEAR SAFETY AUTHORITY
6, place du Colonel Bourgoin
75012 Paris, France
Telephone + 33 (0)1 40 19 86 00
Fax + 33 (0)1 40 19 86 69